ADVANCED FIRMING AND ANTI-WRINKLE MOISTURIZER DAY BROAD SPECTRUM SPF18 SUNSCREEN- avobenzone, octisalate, octocrylene cream

Advanced Firming and Anti-Wrinkle Moisturizer Day Broad Spectrum SPF18 Sunscreen by

Drug Labeling and Warnings

Advanced Firming and Anti-Wrinkle Moisturizer Day Broad Spectrum SPF18 Sunscreen by is a Otc medication manufactured, distributed, or labeled by Emilia Personal Care Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Avobenzone 2.0%
Octisalate 5.0%
Octocrylene 5.0%

Purpose

Sunscreen

Uses

• 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 use and ask a doctor

• if rash occurs.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Apply liberally 15 minutes before sun exposure.
• Reapply at least every 2 hours
• Use water resistant sunscreen 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 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 the product in this container from excessive heat and direct sun

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

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 moisturization

FORMULA ESSENTIALS

• UV SPF18 sunscreen
• Non-Comedogenic
• Dermatologist tested for gentleness
• 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

INGREDIENTS AND APPEARANCE

ADVANCED FIRMING AND ANTI-WRINKLE MOISTURIZER DAY BROAD SPECTRUM SPF18 SUNSCREEN 
avobenzone, octisalate, octocrylene cream

Product 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)