Label: DAILY FACIAL MOISTURIZER BROAD SPECTRUM SPF15 SUNSCREEN- avobenzone, octocrylene cream
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Contains inactivated NDC Code(s)
NDC Code(s): 42421-326-11 - Packager: Emilia Personal Care Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 January 9, 2014
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients
- Purpose
- Uses
- Warnings
- Keep out of reach of children
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Directions
Apply liberally 15 minutes before sun exposure.
Use a water resistant sunscreen if swimming or sweating
Reapply at least every 2 hours
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 Spectrum SPF value of 15 or higher and other sun protection measures including:
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- limit time in the sun, especially from 10 a.m.-2 p.m.
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- wear long-sleeved shirts, pants, hats and sunglasses
- Other Information
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Inactive ingredients
water, diisopropyl adipate, cyclopentasiloxane, glycerin, glyceryl stearate, PEG-100 stearate, titanium dioxide, alumina, simethicone, cetyl alcohol, polymethyl methacrylate, phenoxyethanol, triethanolamine, benzyl alcohol, xanthan gum, acrylates/C10-30 alkyl acrylate crosspolymer, tocopheryl acetate (vitamin E), carbomer, potassium cetyl phosphate, disodium EDTA.
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Package/Label Principal Display Panel
America's Choice® daily facial moisturizer
non-greasy and lightweight
non-comedogenic
(won't clog pores)
fragrance-free & paba-free
dermatologist tested
*Compare to Cetaphil® Daily Facial Moisturizer SPF 15 ingredients
BROAD SPECTRUM SPF15 SUNSCREEN
UVA/UVB PROTECTION
4 FL OZ (118 mL)
*This product is not manufactured or distributed by Galderma®, owner of the registered trademark Cetaphil®
DISTRIBUTED BY ONPOINT, INC.
2 PARAGON DRIVE
MONTVALE, NJ 07645Manufactured in Israel 2T326 AD C1
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INGREDIENTS AND APPEARANCE
DAILY FACIAL MOISTURIZER BROAD SPECTRUM SPF15 SUNSCREEN
avobenzone, octocrylene creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42421-326 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 10 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIISOPROPYL ADIPATE (UNII: P7E6YFV72X) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL 1-STEARATE (UNII: 258491E1RZ) PEG-100 STEARATE (UNII: YD01N1999R) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) ALUMINUM OXIDE (UNII: LMI26O6933) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CETYL ALCOHOL (UNII: 936JST6JCN) POLY(METHYL ACRYLATE-CO-METHYL METHACRYLATE-CO-METHACRYLIC ACID 7:3:1; 280000 MW) (UNII: 99Q3C7L77T) PHENOXYETHANOL (UNII: HIE492ZZ3T) TROLAMINE (UNII: 9O3K93S3TK) BENZYL ALCOHOL (UNII: LKG8494WBH) XANTHAN GUM (UNII: TTV12P4NEE) CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) EDETATE DISODIUM (UNII: 7FLD91C86K) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42421-326-11 1 in 1 CARTON 1 118 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 01/10/2014 Labeler - Emilia Personal Care Inc. (965445112)
