MedPath

Nova Bright Skin SPF 30

Nova Bright Skin Cream SPF 30

Approved
Approval ID

1c201147-7a54-41b5-bdf0-394e3d7efc0c

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Jul 1, 2025

Manufacturers
FDA

Innovation Brands Inc.

DUNS: 134460556

Products 1

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

Octinoxate, Homosalate, Octisalate, Oxybenzone, Avobenzone

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code72104-362
Application NumberM020
Product Classification
M
Marketing Category
C200263
G
Generic Name
Octinoxate, Homosalate, Octisalate, Oxybenzone, Avobenzone
Product Specifications
Route of AdministrationTOPICAL
Effective DateJuly 1, 2025
FDA Product Classification

INGREDIENTS (21)

OCTINOXATEActive
Quantity: 7.4 g in 100 g
Code: 4Y5P7MUD51
Classification: ACTIB
HOMOSALATEActive
Quantity: 6.2 g in 100 g
Code: V06SV4M95S
Classification: ACTIB
OCTISALATEActive
Quantity: 5 g in 100 g
Code: 4X49Y0596W
Classification: ACTIB
OXYBENZONEActive
Quantity: 3.1 g in 100 g
Code: 95OOS7VE0Y
Classification: ACTIB
AVOBENZONEActive
Quantity: 1.5 g in 100 g
Code: G63QQF2NOX
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ALKYL (C12-15) BENZOATEInactive
Code: A9EJ3J61HQ
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
GLYCERYL 1-STEARATEInactive
Code: 258491E1RZ
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
PEG-100 MONOSTEARATEInactive
Code: YD01N1999R
Classification: IACT
TOCOPHEROLInactive
Code: R0ZB2556P8
Classification: IACT
VITAMIN A PALMITATEInactive
Code: 1D1K0N0VVC
Classification: IACT
ALOE VERA LEAFInactive
Code: ZY81Z83H0X
Classification: IACT
GREEN TEA LEAFInactive
Code: W2ZU1RY8B0
Classification: IACT
SODIUM PYRROLIDONE CARBOXYLATEInactive
Code: 469OTG57A2
Classification: IACT
POLYSORBATE 60Inactive
Code: CAL22UVI4M
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
TROLAMINEInactive
Code: 9O3K93S3TK
Classification: IACT
PHENOXYETHANOLInactive
Code: HIE492ZZ3T
Classification: IACT
ETHYLHEXYLGLYCERINInactive
Code: 147D247K3P
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 2/1/2021

Package/Label Principal Display Panel – Carton Label

celestolite**®**

NOVA BRIGHT SKIN CREAM
Nova Crème Peau Radieuse
55g / 1.94oz

SPF30
BROAD
SPECTRUM

20255 CORISCO ST. CHATSWORTH, CA 91311
WWW.CELESTOLITE.COM
image-01

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 2/1/2021

Uses

Helps prevent sunburn.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 2/11/2018

Active Ingredients

Ethylhexyl Methoxycinnamate 7.40%
Homosalate 6.20%
Ethylhexyl Salicylate 5.00%
Benzophenone-3 3.10%
Butyl Methoxydibenzoylmethane 1.50%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 2/11/2018

Purpose

Sunscreen

WARNINGS SECTION

LOINC: 34071-1Updated: 2/11/2018

Warnings

For external use only. Do not use on damaged or broken skin.

Keep out of eyes.

If contact occurs, rinse with water. If rash or irritation develops, discontinue use and consult your physician.

Stop using this product

and ask doctor if rash or redness develops and lasts.

Keep out of reach of children.

If accidental ingestion, call the Poison Control Center right away.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 2/11/2018

Inactive Ingredients

Aqua, C12-15 Alkyl Benzoate, Glycerin, Glyceryl Stearate, Stearic Acid, PEG-100 Stearate, Tocopherol, Retinyl Palmitate, Aloe Barbadensis Leaf Extract, Camellia Sinensis Extract, Sodium PCA, Meteorite Powder, Polysorbate 60, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Carbomer, Disodium EDTA, Triethanolamine, Phenoxyethanol, Ethylhexylglycerin, Fragrance.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 2/1/2021

Directions

After cleansing, apply liberally and evenly 15 minutes before sun exposure. Smooth over face and neck and chest daily for optimal results.

Reapply at least every two (2) hours.

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 value of 15 or higher and other sun protection measures including:

limit time in the sun, especially from 10 a.m.-2 p.m.

wear long-sleeved shirts, pants, hats, and sunglasses

For children under 6 months of age: Ask doctor.

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 2/11/2018

Other Information

Protect the product in this container from excessive heat and direct sun. Store at room temperature.

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