DRUG FACTS

Active Ingredients

Avobenzone 1.6%

Octinoxate 1.6%

Octocrylene 0.8%

Purpose

Sunscreen

Use

Helps prevent sunburn.

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 occurs.

Keep out of reach of children.

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

Directions

Apply liberally 15 minutes before sun exposure.
Use a water resistant sunscreen if swimming or sweating.
Reapply at least every 2 hours.
Spending time in the sun increases your risk of skin cancer and early skin ageing. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: Sun Protection Measures.
limit time in the sun, especially from 10am to2pm.
wear long-sleeved shirts, pants, hats and sunglasses.
Children under 6 months of age: Ask a doctor.

Other Information

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

Inactive Ingredients

Aqua (Water/Eau), Caramel, Glycerin, Butylene glycol, Caprylic/Capric triglyceride, glyceryl stearate SE, Phenoxyethanol, Saccharide isomerate, Sodium ascorbyl phosphate, Sodium stearoyl glutamate, Mica, Benzyl alcohol, Parfum (Fragrance), Allantoin, Disodium EDTA, Tocopheryl acetate, Xanthan gum, Limonene, Lecithin, Sodium hyaluronate, Linalool, Dehydroacetic acid, Citronellol, Evernia prunastri (Oakmoss) Extract, Citric acid, Sodium citrate, Geraniol, Eugenol, CI 77491 (Iron Oxides).

*Naturally occuring in essential oils.

Package Labeling:

Carton Label

PERFECT LEGS SKIN PROTECTOR SPF 30
avobenzone, octinoxate, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71278-005
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	16 mg in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	16 mg in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	8 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
CARAMEL (UNII: T9D99G2B1R)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SACCHARIDE ISOMERATE (UNII: W8K377W98I)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
MICA (UNII: V8A1AW0880)
BENZYL ALCOHOL (UNII: LKG8494WBH)
ALLANTOIN (UNII: 344S277G0Z)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
XANTHAN GUM (UNII: TTV12P4NEE)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
EVERNIA PRUNASTRI (UNII: O3034Q5AHK)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
GERANIOL (UNII: L837108USY)
EUGENOL (UNII: 3T8H1794QW)
FERRIC OXIDE RED (UNII: 1K09F3G675)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:71278-005-01	1 in 1 CARTON	05/16/2017
1		100 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	05/13/2017

Labeler - THIS WORKS PRODUCTS LIMITED (211715561)

Perfect Legs Skin Protector SPF 30