Active ingredients

Octinozate 7.5% ,Octisalate 5%, and Zinc Oxide 4.5%

Purpose

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:

apply liberally 15 minutes before sun exposure
reapply:
immediately after towel drying
at least every 2 hours
Sun Protection Measures: Spending time in the sun increases your risk of skin cancer & early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher & 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

acrylamide sodium acrylate copolymer, aloe barbadensis leaf juice, camellia sinensis (green tea) leaf extract, caprylic/capric tiglyceride, cetearyl alcohol, ethylhexylglycerin, fragrance, glycerin, glyceryl stearate, helianthus annuus (sunflower) seed oil, mineral oil, phenoxyethanol, propylene glycol, sodium cocoyl glucamate, sodium hydroxide, stearic acid, tocopheryl acetate, trideceth-6, water.

Other information

protect this product from excessive heat and direct sun
may stain or damage some fabrics or sufaces

Questions or comments?

SolScents, LLC

2200 N.W. 92nd Avenue.

Miami, FL 33172

PRINCIPAL DISPLAY PANEL - 100 mL Bottle Label

SolScents

SUNSCREEN

CLEAR FACE

SKIN NOUISHING ANTIOXIDANTS

FLOWER BLAST

Broad Spectrum SPF50

Paraben Free

Ultra-light

MADE IN TE USA

3.4 FL OZ (100 mL)

SOLSCENTS CLEAR FACE FLOWER BLAST BROAD SPECTRUM SPF 50
octinoxate, octisalate, and zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58443-0175
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	76.5 mg in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	51 mg in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	45.9 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
SODIUM HYDROXIDE (UNII: 55X04QC32I)
STEARIC ACID (UNII: 4ELV7Z65AP)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TRIDECETH-6 (UNII: 3T5PCR2H0C)
WATER (UNII: 059QF0KO0R)
CAPRYLIC/CAPRIC MONO/DIGLYCERIDES (UNII: U72Q2I8C85)
SODIUM ACRYLOYLDIMETHYLTAURATE-ACRYLAMIDE COPOLYMER (1:1; 90000-150000 MPA.S) (UNII: 5F4963KLHS)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
SUNFLOWER SEED OIL GLYCERETH-8 ESTERS (UNII: 358X17CAT0)
MINERAL OIL (UNII: T5L8T28FGP)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:58443-0175-3	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/01/2015

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	04/01/2015

Labeler - Prime Enterprises, Inc. (101946028)

Registrant - Prime Enterprises, Inc. (101946028)

Name	Address	ID/FEI	Business Operations
Establishment
Prime Enterprises, Inc.		101946028	label(58443-0175) , pack(58443-0175) , manufacture(58443-0175) , analysis(58443-0175)