PRO TRIPLE PROTECTION FACTOR FACE AND BODY BROAD SPECTRUM SPF 30 SUNSCREEN- octinoxate, oxybenzone, octisalate, octocrylene, avobenzone lotion

PRO TRIPLE PROTECTION FACTOR FACE AND BODY BROAD SPECTRUM SPF 30 SUNSCREEN by

Drug Labeling and Warnings

PRO TRIPLE PROTECTION FACTOR FACE AND BODY BROAD SPECTRUM SPF 30 SUNSCREEN by is a Otc medication manufactured, distributed, or labeled by ELIZABETH ARDEN, INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

OCTINOXATE 7.5 % W/W

OXYBENZONE 5.0 % W/W

OCTISALATE 5.0 % W/W

OCTOCRYLENE 5.0 % W/W

AVOBENZONE 3.0 % W/W

Purpose

Sunscreen

Sunscreen

Sunscreen

Sunscreen

Sunscreen

Uses

• Helps prevent sunburn
• If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

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 product is swallowed, get medical help or contact a Poison Control Center right away.

Directions For Sunscreen Use:

• Apply liberally 15 minutes before sun exposure
• Reapply:
  • At least every 2 hours
  • Use a 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 10 a.m. – 2 p.m.
  • Wear long-sleeve shirts, pants, hats, and sunglasses
• Children under 6 months: Ask a doctor.

Inactive Ingredients

WATER/AQUA/EAU, NYLON-12, BUTYLENE GLYCOL, C12-15 ALKYL BENZOATE, DIMETHICONE, PENTYLENE GLYCOL, CETEARYL ALCOHOL, CAPRYLYL METHICONE, ACETYL FARNESYLCYSTEINE, AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER, ARABIDOPSIS THALIANA EXTRACT, CAPRYLYL GLYCOL, CARNOSINE, CETETH-20 PHOSPHATE, CHONDRUS CRISPUS EXTRACT, COCO-GLUCOSIDE, DICETYL PHOSPHATE, DISODIUM EDTA, ERGOTHIONEINE, HYDROXYACETOPHENONE, LECITHIN, MICROCOCCUS LYSATE, PLANKTON EXTRACT, SODIUM HYALURONATE, SODIUM PCA, TOCOPHERYL ACETATE, BHT, CHLORPHENESIN, PHENOXYETHANOL, POTASSIUM SORBATE, SODIUM DEHYDROACETATE.

Other Information

• Protect this product from excessive heat and direct sun
• Store at room temperature

Questions or comments?

Call toll free 1-844-273-3679

Principal Display Panel - Bottle Label

ElizabethArden

PRO

TRIPLE
PROTECTION
FACTOR
FACE & BODY

Broad Spectrum
SPF 30 Sunscreen
Lotion

with DNA Enzyme Complex™
+ Antioxidants

4 FL. OZ. (120 ml)

Principal Display Panel - Carton Label

ElizabethArden

PRO

TRIPLE
PROTECTION
FACTOR
FACE & BODY

Broad Spectrum
SPF 30 Sunscreen
Lotion

with DNA Enzyme Complex™
+ Antioxidants

4 FL. OZ. (120 ml)

INGREDIENTS AND APPEARANCE

PRO TRIPLE PROTECTION FACTOR FACE AND BODY BROAD SPECTRUM SPF 30 SUNSCREEN 
octinoxate, oxybenzone, octisalate, octocrylene, avobenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67938-2076
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	.07575 g  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	.06 g  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	.0505 g  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	.0525 g  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	.03237 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
NYLON-12 (UNII: 446U8J075B)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
DIMETHICONE (UNII: 92RU3N3Y1O)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
CETETH-20 PHOSPHATE (UNII: 921FTA1500)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
COCO GLUCOSIDE (UNII: ICS790225B)
CARNOSINE (UNII: 8HO6PVN24W)
DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CHLORPHENESIN (UNII: I670DAL4SZ)
ACETYL FARNESYLCYSTEINE (UNII: KK6984C8O3)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
CHONDRUS CRISPUS CARRAGEENAN (UNII: UE856F2T78)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
ARABIDOPSIS THALIANA (UNII: AI3L60HQ81)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
ERGOTHIONEINE (UNII: BDZ3DQM98W)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67938-2076-1	1 in 1 BOX	02/01/2017
1	NDC: 67938-2076-2	120 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	02/01/2017

Labeler - ELIZABETH ARDEN, INC (849222187)