SUNFROG ULTRA SPF 30 LIP BALM- octinoxate, octocrylene, oxybenzone, octisalate, petroleum jelly stick
OraLabs

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active ingredient

Octinoxate (7.5%), Octocrylene (7.0%), Oxybenzone (5.0%), Octisalate (5.0%), Petrolatum (30.0%)

Purpose

Sunscreen, Sunscreen, Sunscreen, Sunscreen, Skin Protectant

Keep Out of Reach of Children

If swallowed get medical help or contact a Poison Control Center right away.

Uses

Prevents Sunburns

Warnings

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early aging.

For external use only: Stop use and ask a doctor: if rash or irritation develops and lasts.

Directions

Apply liberally before sun exposure and as needed. Children under 6 months of age: Ask a doctor before use.

Inactive Ingredients

Synthetic Beeswax, Cetyl Alcohol, Mineral Oil, Paraffin, Polyethylene, Flavor, Caprylic/Capric Triglyceride, Titanium Dioxide (CI 77891), Stearic Acid, Aluminum Hydroxide, Lanolin, Phenyl Trimethicone, Oleyl Alcohol, Isopropyl Lanolate, Isopropyl Myristate, BHT, Tocopheryl Acetate, Propyl paraben, Aloe Barbadensis Leaf Extract, Methylparaben, Sodium Saccharin.

Package/Label Principal Display Panel

SUNFROG ULTRA SPF 30 LIP BALM
octinoxate, octocrylene, oxybenzone, octisalate, petroleum jelly stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63645-165
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 mg in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	5.0 mg in 1 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	30.0 mg in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	7.0 mg in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5.0 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
LIGHT MINERAL OIL (UNII: N6K5787QVP)	7.0 mg in 1 g
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)	.1 mg in 1 g
WHITE WAX (UNII: 7G1J5DA97F)	16.8 mg in 1 g
CETYL ALCOHOL (UNII: 936JST6JCN)	7.0 mg in 1 g
METHYLPARABEN (UNII: A2I8C7HI9T)	0.1 mg in 1 g

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor	VANILLA	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63645-165-01	1 g in 1 CONTAINER; Type 0: Not a Combination Product	11/29/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	11/29/2017

Labeler - OraLabs (801824756)

Registrant - OraLabs (801824756)

Name	Address	ID/FEI	Business Operations
Establishment
OraLabs		801824756	MANUFACTURE(63645-165) , LABEL(63645-165)