MedPath

Sunscreen Karina Skin Care Moist

Sunscreen Karina Skin care Moist Sunscreen

Approved
Approval ID

bf7c64f7-93f4-58f1-e053-2a95a90a3ce6

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Jul 6, 2025

Manufacturers
FDA

CA-Botana International

DUNS: 106276728

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Octinoxate, Zinc Oxide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code35192-033
Application NumberM020
Product Classification
M
Marketing Category
C200263
G
Generic Name
Octinoxate, Zinc Oxide
Product Specifications
Route of AdministrationTOPICAL
Effective DateJuly 6, 2025
FDA Product Classification

INGREDIENTS (40)

BUTYLOCTYL SALICYLATEInactive
Code: 2EH13UN8D3
Classification: IACT
MATRICARIA RECUTITA FLOWERING TOPInactive
Code: 3VNC7T6Z02
Classification: IACT
JUNIPERUS COMMUNIS STEMInactive
Code: HBU87MH6OY
Classification: IACT
ROSEMARYInactive
Code: IJ67X351P9
Classification: IACT
HEXASODIUM PHYTATEInactive
Code: ZBX50UG81V
Classification: IACT
POLAWAX POLYSORBATEInactive
Code: Q504PL8E0V
Classification: IACT
ACEROLAInactive
Code: XDD2WEC9L5
Classification: IACT
PHENOXYETHANOLInactive
Code: HIE492ZZ3T
Classification: IACT
ZINC OXIDEActive
Quantity: 9.919 g in 141.7 g
Code: SOI2LOH54Z
Classification: ACTIB
ACETYL TETRAPEPTIDE-5Inactive
Code: Y1DFQ308G8
Classification: IACT
ASCORBYL PALMITATEInactive
Code: QN83US2B0N
Classification: IACT
WHITE TEAInactive
Code: O0M3396E09
Classification: IACT
ALLANTOINInactive
Code: 344S277G0Z
Classification: IACT
OLIVE OILInactive
Code: 6UYK2W1W1E
Classification: IACT
ETHYL FERULATEInactive
Code: 5B8915UELW
Classification: IACT
ACAIInactive
Code: 46AM2VJ0AW
Classification: IACT
GINKGO BILOBA ROOTInactive
Code: 1XUK686051
Classification: IACT
JOJOBA OILInactive
Code: 724GKU717M
Classification: IACT
TOCOPHEROLInactive
Code: R0ZB2556P8
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
POTASSIUM SORBATEInactive
Code: 1VPU26JZZ4
Classification: IACT
CETEARYL ISONONANOATEInactive
Code: P5O01U99NI
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
ALOE VERA LEAFInactive
Code: ZY81Z83H0X
Classification: IACT
CETYL ALCOHOLInactive
Code: 936JST6JCN
Classification: IACT
PROPANEDIOLInactive
Code: 5965N8W85T
Classification: IACT
ETHYLHEXYLGLYCERINInactive
Code: 147D247K3P
Classification: IACT
ASCORBIC ACIDInactive
Code: PQ6CK8PD0R
Classification: IACT
OCTINOXATEActive
Quantity: 10.62 g in 141.7 g
Code: 4Y5P7MUD51
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
CETEARETH-22Inactive
Code: 28VZG1E234
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
COCO-CAPRYLATE/CAPRATEInactive
Code: 8D9H4QU99H
Classification: IACT
TRIETHOXYCAPRYLYLSILANEInactive
Code: LDC331P08E
Classification: IACT
CETOSTEARYL ALCOHOLInactive
Code: 2DMT128M1S
Classification: IACT
ALLYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (LOW ALLYL METHACRYLATE)Inactive
Code: PI80E777XB
Classification: IACT
ALPHA-TOCOPHEROL ACETATEInactive
Code: 9E8X80D2L0
Classification: IACT
ALMOND OILInactive
Code: 66YXD4DKO9
Classification: IACT
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7U
Classification: IACT
CARBOMER INTERPOLYMER TYPE A (55000 CPS)Inactive
Code: 59TL3WG5CO
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 4/30/2021

KarinaJPEG.jpg

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 8/15/2016

Indications & Usage

Apply liberally 15 minutes before exposure, use water resistant sunscreen, if swimming or sweating. reapply at least every 2 hours. Children under 6 months: ask a doctor

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 4/30/2021

Active Ingredient

Octinoxate 7.5%.............................................Sunscreen

Zinc Oxide 7.0%............................................. Sunscreen

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 4/30/2021

Purpose

Sunscreen

OTC - ASK DOCTOR SECTION

LOINC: 50569-3Updated: 4/30/2021

Ask Doctor

Stop use and ask a doctor if rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 4/30/2021

Keep out of reach of children

Keep out of reach of children

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 4/30/2021

Inactive Ingredients

Water (Aqua), Glycerine, Cetearyl isononanoate, Coco caprylate caprate, Prunus amygdalus dulcis (Sweet Almond) oil, Caprylic/Capric triglyceride, Cetyl alcohol, Propanediol, Aloe barbadensis leaf extract, Ascorbic acid, Ascorbyl palmitate, Olea europaea (Olive) leaf , Potassium sorbate, Rosmarinus officinalis (Rosemary) leaf, Tocopherol, Xanthan gum, Citric acid, Ethylhexylglycerin, Phenoxyethanol, Acrylates C10-30 Alkyl Acrylate Crosspolymer,Alpha Acetyl Tetrapeptide - 5, Butyloctyl Salicylate, Camellia sinensis (White tea) Leaf extract, Cetearyl Alcohol, Ceteareth-20, Chamomillla recutita (Matricaria)Flower extract, Emulsifying wax, Ethyl Ferulate, Euterpe Oleracea (Acai) Fruit extract, Ginkgo Biloba leaf extract, Juniperus communis (Juniper) Fruit, Malpighia punicifolia (Acerola) Fruit extract, Simmondsia chinensis (Jojoba) Seed oil, Sodium Phytate. Tocopheryl Acetate, Triethoxycaprylylsilane.

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 4/30/2021

Safety information

Protect this product from excessive heat and direct sun

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 4/30/2021

Dosage & Administration

Helps prevent sunburn. If used as directed with other sun protection measured decreases the risk of skin cancer and early skin aging caused by the sun. Apply liberally 15 minutes before sun exposure. Usea water resistant sunscreen if swimming or sweating. Reapply : at least 2 hours. Children under 6 months: Ask a doctor. Sun protections measurements. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and othe sun protection measures including: limit time in the sun, specially from 10 a.m.- 2 p.m Wear long-sleeveshirts, pants, hats, and sunglasses. Protect this product from excessive heat and direct sun.

WARNINGS SECTION

LOINC: 34071-1Updated: 8/15/2016

Warnings

For external use only. Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove. If product is swallowed get medical help or contact a poison Control Center right away.

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Sunscreen Karina Skin Care Moist - FDA Drug Approval Details