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bleve

Topco Associates LLC
APOLLO HEALTH AND BEAUTY CARE

DRUG FACTS


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

ACTIVE INGREDIENT

OCTYL METHOXYCINNAMATE 2%

AVOBENZONE 0.5%

PURPOSE

SKIN PROTECTANT

SKIN PROTECTANT

USES

HELPS PREVENT SUNBURN.

WARNINGS

FOR EXTERNAL USE ONLY.

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 HELP PREVENT SUNBURN, NOT SKIN CANCER OR EARLY SKIN AGING.

WHEN USING THIS PRODUCT

AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE EYES THOROUGHLY WITH WATER.

STOP USING THIS PRODUCT AND ASK A DOCTOR IF

IRRITATION OR REDNESS DEVELOPS AND LASTS.

KEEP OUT OF REACH OF CHILDREN

IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

DIRECTIONS

APPLY LIBERALLY 15 MINUTES BEFORE EXPOSURE TO SUN. USE A WATER RESISTANT SUNSCREEN IF SWIMMING OR SWEATING. REAPPLY AT LEAST EVERY TWO HOURS. FOR CHILDREN UNDER 6 MONTHS, ASK A DOCTOR.

INACTIVE INGREDIENTS

WATER (AQUA), CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES, GLYCINE SOJA (SOYBEAN) OIL, C12-15 ALKYL BENZOATE, POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE, GLYCERYL STEARATE, CETYL ALCOHOL, STEARYL ALCOHOL, DIMETHICONE,VITIS VINIFERA (GRAPE) FRUIT CELL EXTRACT, ISOMALT, LECITHIN, SODIUM BENZOATE, PALMITOYL TRIPEPTIDE-38, GLYCERIN, HYDROXYPROPYL CYCLODEXTRIN, INULIN, AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER, FRAGRANCE (PARFUM), PHENOXYETHANOL, TROPOLONE.

LABEL COPY

bleve

bleve

Octyl Methoxycinnamate LOTION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:36800-353
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 2 mL
AVOBENZONE AVOBENZONE 0.5 mL

Inactive Ingredients

Ingredient Name Strength
water
CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES
SOYBEAN OIL
ALKYL (C12-15) BENZOATE
Polyglycerin-3
GLYCERYL MONOSTEARATE
CETYL ALCOHOL
stearyl alcohol
DIMETHICONE
VITIS VINIFERA FLOWERING TOP
ISOMALT
LECITHIN, SOYBEAN
SODIUM BENZOATE
PALMITOYL TRIPEPTIDE-5
GLYCERIN
Hydroxypropylbetadex (0.58-0.68 MS)
INULIN
CARBOMER COPOLYMER TYPE A
PHENOXYETHANOL
TROPOLONE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:36800-353-04 118 in 1 JAR

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2012-03-19


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