Label: EQUATE- avobenzone, octisalate, octocrylene cream
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Contains inactivated NDC Code(s)
NDC Code(s): 49035-818-18 - Packager: Wal-Mart Stores, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated May 10, 2018
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Directions •apply liberally 15 minutes before sun
exposure •reapply at least every 2 hours •use water
resistant sunscrenn if swimming or sweating •children
under 6 months of age: ask a doctor
•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 SpectrumSPF
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.
- STORAGE AND HANDLING
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INACTIVE INGREDIENT
Inactive ingredients Water, Cyclopentasiloxane, Glycerin, Glyceryl Stearate,
PEG-100 Stearate, Caprylic/Capric Triglyceride, Beeswax, Simmondsia Chinensis (Jojoba) Seed Oil,
Myristyl Myristate, Cetearyl Alcohol, Stearic Acid, Squalane, Polyglyceryl-10 Pentastearate,
Behenyl Alcohol, Sodium Steroyl Lactylate, Phenoxyethanol, Ethylhexylglycerin,
Diethylhexyl 2,6-Naphthalate, Polyacrylate-13, Polyisobutene, Polysorbate 20,
Butylene Glycol, Carbomer, Palmitoyl Tripeptide-1, Palmitoyl Tetrapeptide-7,
Steareth-2, Tocopheryl Acetate (Vitamin E), Triethanolamine, Fragrance,
Lecithin, Soy Isoflavones, Polysorbate 80, Xanthan Gum, Titanium Dioxide,
Trimethoxycaprylylsilane, Allantoin, Disodium EDTA, Dipalmitoyl Hydroxyproline,
Glycine Soja (Soybean) Protein, Retinyl Palmitate (Vitamin A).
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
EQUATE
avobenzone, octisalate, octocrylene creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49035-818 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE .96 g in 48 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 2.41 g in 48 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 2.41 g in 48 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PEG-100 STEARATE (UNII: YD01N1999R) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) YELLOW WAX (UNII: 2ZA36H0S2V) JOJOBA OIL (UNII: 724GKU717M) MYRISTYL MYRISTATE (UNII: 4042ZC00DY) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) STEARIC ACID (UNII: 4ELV7Z65AP) SQUALANE (UNII: GW89575KF9) POLYGLYCERYL-10 PENTASTEARATE (UNII: PMX5872701) DOCOSANOL (UNII: 9G1OE216XY) SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN) PHENOXYETHANOL (UNII: HIE492ZZ3T) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM) SODIUM ACRYLATE (UNII: 7C98FKB43H) POLYISOBUTYLENE (1300 MW) (UNII: 241BN7J12Y) POLYSORBATE 20 (UNII: 7T1F30V5YH) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) CARBOMER 940 (UNII: 4Q93RCW27E) PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M) PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R) STEARETH-2 (UNII: V56DFE46J5) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) TROLAMINE (UNII: 9O3K93S3TK) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) SOY ISOFLAVONES (UNII: 71B37NR06D) POLYSORBATE 80 (UNII: 6OZP39ZG8H) XANTHAN GUM (UNII: TTV12P4NEE) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIMETHOXYCAPRYLYLSILANE (UNII: FZ07E4LW2M) ALLANTOIN (UNII: 344S277G0Z) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H) SOY PROTEIN (UNII: R44IWB3RN5) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49035-818-18 1 in 1 CARTON 05/10/2018 1 48 g in 1 JAR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 05/10/2018 Labeler - Wal-Mart Stores, Inc. (051957769)
