Label: ADVANCED FIRMING AND ANTI-WRINKLE MOISTURIZER DAY BROAD SPECTRUM SPF18 SUNSCREEN- avobenzone, octisalate, octocrylene cream
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Contains inactivated NDC Code(s)
NDC Code(s): 42421-815-11 - 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 10, 2014
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- Official Label (Printer Friendly)
- Active ingredient
- Purpose
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Uses
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- helps prevent sunburn
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- 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
- Do not use on
- When using this product
- Stop use and ask a doctor
- Keep out of reach of children.
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Directions
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- Apply liberally 15 minutes before sun exposure.
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- Reapply at least every 2 hours
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- Use water resistant sunscreen if swimming or sweating
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- Children under 6 months of age: ask a doctor
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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, cyclohexasiloxane, glycerin, titanium dioxide, glyceryl stearate, PEG-100 stearate, beeswax, myristyl myristate, stearic acid, palmitic acid, polyglyceryl-10 pentastearate, behenyl alcohol, sodium steroyl lactylate, tocopheryl acetate (vitamin E), butylene glycol, carbomer, polysorbate 20, palmitoyl oligopeptide, palmitoyl tetrapeptide-7, propylene glycol, diazolidinyl urea, methylparaben, propylparaben, cetyl alcohol,stearyl alcohol, hydrolyzed soy protein, dipalmitoyl hydroxyproline, fragrance, triethanolamine, glycine soja (soybean) protein, xanthan gum, retinyl palmitate (vitamin A), phenoxyethanol, PEG-20 stearate, potassium sorbate, sodium benzoate, phenethyl alcohol, alcohol denat., chlorphenesin
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Package/Label Principal Display Panel
America's Choice
advanced firming & anti-wrinkle moisturizer
with encapsulated Pro-Vitamin A & Matrixyl™ & Sepilift™*compare to L’Oreal® advanced revitalift® complete day cream SPF18 ingredients
DAY CREAM BROAD SPECTRUM SPF 18 SUNSCREEN
NET WT 1.7 OZ (48 g)
TRIPLE-ACTION TECHNOLOGY
Advanced Anti-Wrinkle Action: Encapsulated Pro-Vitamin A and Sepilift™ will hasten skin renewal reducing the amount of fine lines and wrinkles and their depth. Results can be seen in just two weeks. The newtechnology will continually act to help fight the signs of aging.Innovative Firming; Matrixyl™ has proven to show renewed elastin and collagen fibers*. Skin’s surface is remodeled, becoming more resilient and toned.
Continuous Moisturization & Skin Protection; Provides 24 hour moisturization to soothe dry skin. Broad spectrum UVA/UVB SPF18 protects the skin and prevents damage by UV exposure.
Directions for Use; Every day, smooth gently onto face and neck until thoroughly absorbed. Use in the AM, alone or under makeup.
Results; Skin’s elasticity is improved. Visible reduction of wrinkles and skin looks smoother, Firmer skin
Matrixyl™ is a registered trademark owned by Sederma.
Sepilift™ is a registered trademark owned by Seppic.*In-vitro testing
FIRMING & ANTI-WRINKLE; AN INNOVATIVE TECHNOLOGY
Now experience the advanced actions against the signs of skin aging. New Firming & Anti-Wrinkle Day Cream Broad Spectrum SPF18 Sunscreen, with effective encapsulated Pro-Vitamin A, Matrixyl™ & Sepilift™ will increase cell turnover, reduce wrinkles, firm the skin, and provide 24 hour moisturizationFORMULA ESSENTIALS
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- UV SPF18 sunscreen
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- Non-Comedogenic
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- Dermatologist tested for gentleness
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- Non-greasy
Manufactured in Israel 37815 AD C1
*This product is not manufactured or distributed by L’Oreal, owner of the registered trademark Revitalift®.
Carton Label
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INGREDIENTS AND APPEARANCE
ADVANCED FIRMING AND ANTI-WRINKLE MOISTURIZER DAY BROAD SPECTRUM SPF18 SUNSCREEN
avobenzone, octisalate, octocrylene creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42421-815 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 2 g in 100 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 5 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 6 (UNII: XHK3U310BA) GLYCERIN (UNII: PDC6A3C0OX) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PEG-100 STEARATE (UNII: YD01N1999R) YELLOW WAX (UNII: 2ZA36H0S2V) MYRISTYL MYRISTATE (UNII: 4042ZC00DY) STEARIC ACID (UNII: 4ELV7Z65AP) PALMITIC ACID (UNII: 2V16EO95H1) DOCOSANOL (UNII: 9G1OE216XY) SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) POLYSORBATE 20 (UNII: 7T1F30V5YH) PALMITOYL OLIGOPEPTIDE (UNII: HO4ZT5S86C) PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) CETYL ALCOHOL (UNII: 936JST6JCN) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H) TROLAMINE (UNII: 9O3K93S3TK) XANTHAN GUM (UNII: TTV12P4NEE) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) PHENOXYETHANOL (UNII: HIE492ZZ3T) PEG-20 STEARATE (UNII: NBX892EA57) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) SODIUM BENZOATE (UNII: OJ245FE5EU) PHENYLETHYL ALCOHOL (UNII: ML9LGA7468) ALCOHOL (UNII: 3K9958V90M) CHLORPHENESIN (UNII: I670DAL4SZ) CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36) SOY PROTEIN (UNII: R44IWB3RN5) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42421-815-11 1 in 1 CARTON 1 48 g in 1 JAR 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)