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CVS PHARMACY

CVS Pharmacy
APOLLO HEALTH AND BEAUTY CARE

DRUG FACTS


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

ACTIVE INGREDIENTS

AVOBENZONE 3%, OCTINOXATE 7.5%, OCTISALATE 2%

PURPOSE

SUNSCREEN

USE(S)

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 USING THIS PRODUCT AND ASK A DOCTOR IF

RASH OCCURS.

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 SUN EXPOSURE. REAPPLY AT LEAST EVERY 2 HOURS. USE A WATER RESISTANT SUNSCREEN IF SWIMMING OR SWEATING. CHILDREN UNDER 6 MONTHS: ASK A DOCTOR.

SUN PROTECTION MEASURES

SPENDING TIME IN THE SUN INCREASES YOUR RISK OF SKIN CANACER AND EARLY SKIN AGING. TO DECREASE THIS RISK, REGULARLY USE A SUNSCREEN WITH A BROAD SPECTRUM SPF VALUE 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-SLEEVED SHIRTS, PANTS, HATS, AND SUNGLASSES.

OTHER INFORMATION

PROTECT THIS PRODUCT FROM EXCESSIVE HEAT AND DIRECT SUN.

INACTIVE INGREDIENTS:

WATER (AQUA), C12-15 ALKYL BENZOATE, CETEARYL ALCOHOL, DIMETHICONE, GLYCINE SOJA (SOYBEAN) SEED EXTRACT, GLYCERIN, BIS-PHENYLPROPYL DIMETHICONE, ARACHIDYL ALCOHOL, PHENOXYETHANOL, CETEARYL GLUCOSIDE, PANTHENOL, BENZYL ALCOHOL, ETHYLENE/ACRYLIC ACID COPOLYMER, BEHENYL ALCOHOL, STEARETH-2, FRAGRANCE (PARFUM), STEARETH-21, POLYACRYLAMIDE, POLYMETHYL METHACRYLATE, ARACHIDYL GLUCOSIDE, DISODIUM EDTA, METHYLPARABEN, C13-14 ISOPARAFFIN, ETHYLPARABEN, BUTYLPARABEN, LAURETH-7, BENZALKONIUM CHLORIDE, PROPYLPARABEN, ISOBUTYLPARABEN, BHT, IODOPROPYNYL BUTYLCARBAMATE, MICA, SILICA, TITANIUM DIOXIDE.

QUESTIONS OR COMMENTS?

1-800-746-7287

LABEL COPY

CVS PHARMACY

LABEL COPY

CVS PHARMACY

CVS PHARMACY

AVOBENZONE, OCTINOXATE, OCTISALATE LOTION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:59779-602
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
AVOBENZONE AVOBENZONE 30 mg
OCTINOXATE OCTINOXATE 75 mg
OCTISALATE OCTISALATE 20 mg

Inactive Ingredients

Ingredient Name Strength
water
C12-15 ALKYL BENZOATE
CETOSTEARYL ALCOHOL
DIMETHICONE
SOYBEAN
GLYCERIN
DIMETHICONE PEG-15 ACETATE
ARACHIDYL ALCOHOL
PHENOXYETHANOL
CETEARYL GLUCOSIDE
PANTHENOL
BENZYL ALCOHOL
TRIMETHYLOLPROPANE TRIACRYLATE
docosanol
STEARETH-2
STEARETH-21
POLYACRYLAMIDE (10000 MW)
METHYL METHACRYLATE
ARACHIDYL GLUCOSIDE
EDETATE DISODIUM
METHYLPARABEN
C13-14 ISOPARAFFIN
ETHYLPARABEN
BUTYLPARABEN
LAURETH-7
benzalkonium chloride
PROPYLPARABEN
isobutylparaben
BUTYLATED HYDROXYTOLUENE
IODOPROPYNYL BUTYLCARBAMATE
MICA
SILICON DIOXIDE
titanium dioxide

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:59779-602-04 118 in 1 BOTTLE, PLASTIC
2 NDC:59779-602-00 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2013-06-10


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