![DAILY FACIAL MOISTURIZER BROAD SPECTRUM SPF15 SUNSCREEN (AVOBENZONE, OCTOCRYLENE) CREAM [EMILIA PERSONAL CARE INC.]](https://medic.hrt.org//dailymed/images/71f476f9-c532-43a3-847b-a4bd3de519c8/71f476f9-c532-43a3-847b-a4bd3de519c8-01.jpg)
| NDC | 42421-326-11 |
| Set ID | 71f476f9-c532-43a3-847b-a4bd3de519c8 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Emilia Personal Care Inc. |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART352 |
- 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:
- •
- limit time in the sun, especially from 10 a.m.-2 p.m.
- •
- 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)
