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DIY Booster SPF 30 Facial Serum Unscented

DIY Booster SPF 30 Facial Serum Unscented

Approved
Approval ID

ebaf5ef7-84aa-4cb1-a701-2e0d0fd357df

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Jun 9, 2025

Manufacturers
FDA

Andalou naturals

DUNS: 011472720

Products 1

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

Octinoxate, Octisalate, Avobenzone, and Zinc Oxide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code55560-0107
Application NumberM020
Product Classification
M
Marketing Category
C200263
G
Generic Name
Octinoxate, Octisalate, Avobenzone, and Zinc Oxide
Product Specifications
Route of AdministrationTOPICAL
Effective DateJune 9, 2025
FDA Product Classification

INGREDIENTS (33)

OCTINOXATEActive
Quantity: 70 mg in 1 mL
Code: 4Y5P7MUD51
Classification: ACTIB
OCTISALATEActive
Quantity: 50 mg in 1 mL
Code: 4X49Y0596W
Classification: ACTIB
AVOBENZONEActive
Quantity: 30 mg in 1 mL
Code: G63QQF2NOX
Classification: ACTIB
ZINC OXIDEActive
Quantity: 1 mg in 1 mL
Code: SOI2LOH54Z
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ALKYL (C12-15) BENZOATEInactive
Code: A9EJ3J61HQ
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
CETYL ALCOHOLInactive
Code: 936JST6JCN
Classification: IACT
STEARYL ALCOHOLInactive
Code: 2KR89I4H1Y
Classification: IACT
POLYSORBATE 20Inactive
Code: 7T1F30V5YH
Classification: IACT
PHENOXYETHANOLInactive
Code: HIE492ZZ3T
Classification: IACT
TOCOPHEROLInactive
Code: R0ZB2556P8
Classification: IACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPEInactive
Code: 0A5MM307FC
Classification: IACT
METHYL DIHYDROABIETATEInactive
Code: 7666FJ0J9F
Classification: IACT
ALUMINUM STARCH OCTENYLSUCCINATEInactive
Code: I9PJ0O6294
Classification: IACT
APPLEInactive
Code: B423VGH5S9
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
SOYBEAN LECITHINInactive
Code: 1DI56QDM62
Classification: IACT
SUNFLOWER OILInactive
Code: 3W1JG795YI
Classification: IACT
ACAIInactive
Code: 46AM2VJ0AW
Classification: IACT
ARONIA MELANOCARPA FRUIT JUICEInactive
Code: D2EVP827PJ
Classification: IACT
LYCIUM BARBARUM FRUITInactive
Code: 930626MWDL
Classification: IACT
TEA LEAFInactive
Code: GH42T47V24
Classification: IACT
TRIETHOXYCAPRYLYLSILANEInactive
Code: LDC331P08E
Classification: IACT
ETHYLHEXYLGLYCERINInactive
Code: 147D247K3P
Classification: IACT
VITIS VINIFERA HIGH TANNIN CULTIVAR FRUIT CELL LYSATEInactive
Code: ZLW3M94UYA
Classification: IACT
ISOMALTInactive
Code: S870P55O2W
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
ASPALATHUS LINEARIS LEAFInactive
Code: H7UGK1GJCU
Classification: IACT
HIBISCUS SABDARIFFA FLOWERInactive
Code: 45TGG6IU6M
Classification: IACT
RESVERATROLInactive
Code: Q369O8926L
Classification: IACT
UBIDECARENONEInactive
Code: EJ27X76M46
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 6/9/2025

PRINCIPAL DISPLAY PANEL - 58 mL Tube Carton

SUNSCREEN

ANDALOU
NATURALS

DIY Booster

SPF 30
FACIAL SERUM

Unscented

with Resveratrol Q10
& Vitamin E

Broad Spectrum SPF 30

FRUIT
STEM
CELL
SCIENCE®

AGE DEFYING

2 fl oz / 58 mL

PRINCIPAL DISPLAY PANEL - 58 mL Tube Carton

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 6/9/2025

Uses

  • Helps prevent sunburn.

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 6/9/2025

Dist. by Andalou Naturals
Novato, CA 94945 USA

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 6/9/2025

Active Ingredient

Purpose

Octinoxate 7%

Sunscreen

Octisalate 5%

Sunscreen

Avobenzone 3%

Sunscreen

Zinc Oxide 0.1%

Sunscreen

WARNINGS SECTION

LOINC: 34071-1Updated: 6/9/2025

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.

  • Stop use and ask a doctor if rash or irritation develops and lasts.

  • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 6/9/2025

Directions

  • Daily, alone or under make-up.
  • Apply liberally 15 minutes before sun exposure and as needed.
  • Reapply every 2 hours or after swimming, towel drying, perspiring heavily, washing, or in the case of products applied to the lips, after eating or drinking.
  • Use water resistant sunscreen if swimming or sweating. *Sun Protection Measures. 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 other sun protection measures including: limit time in the sun, especially from 10am-2pm, wear long sleeve shirts, pants and sunglasses.
  • Children under 6 months: ask a doctor.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 6/9/2025

Inactive Ingredients

Aqua/Water/Eau, C12-15 Alkyl Benzoate, Glycerin, Polysorbate 80, Cetyl Alcohol, Stearyl Alcohol, Polysorbate 20, Phenoxyethanol, Tocopherol, Carbomer, Methyl Dihydroabietate, Aluminum Starch Octenylsuccinate, Malus Domestica (Apple) Fruit Cell Culture Extract, Xanthan Gum, Lecithin, Helianthus Annuus (Sunflower) Seed Oil1, Euterpe Oleracea (Açaí) Fruit Extract1, Aronia Melanocarpa (Black Chokeberry) Fruit Extract1, Lycium Barbarum (Goji) Fruit Extract1, Camellia Sinensis (Tea) Leaf Extract1, Triethyoxycaprylylsilane, Ethylhexylglycerin, Vitis Vinifera (Grape) Fruit Cell Extract, Isomalt, Alcohol, Aspalathus Linearis (Rooibos) Leaf Extract1, Hibiscus Sabdariffa (Roselle) Flower Extract1, Pichia/Resveratrol Ferment Extract, Ubiquinone (CoQ10)


1

**Certified Organic Ingredient**

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 6/9/2025

Other Information

  • Protect the product in this container from excessive heat and direct sun.

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 6/9/2025

Questions

Call (888) 898-6955 or visit www.Andalou.com

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DIY Booster SPF 30 Facial Serum Unscented - FDA Drug Approval Details