Label: ANEW CLINICAL SKINVINCIBLE MULTI-SHIELD- avobenzone, homosalate, octinoxate, octocrylene, oxybenzone lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 10096-0304-1, 10096-0304-2, 10096-0304-3, 10096-0304-4, view more10096-0304-5 - Packager: New Avon LLC
- 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 1, 2019
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- INDICATIONS & USAGE
- WARNINGS
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DOSAGE & ADMINISTRATION
Directions
• apply liberally 15 minutes before sun exposure
• children under 6 months of age: ask a doctor
• reapply at least every 2 hours
• use a water resistant sunscreen if swimming or sweating
• 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 -
INACTIVE INGREDIENT
Inactive ingredients
water/eau, propanediol, butyloctyl salicylate, dimethicone, dilauryl thiodipropionate, polymethylsilsesquioxane, silica, glycerin, cinnamido benzylpiperidinyl ethoxypropylbenzamide, retinol/saccharomyces polypeptide, phyllanthus emblica fruit extract, cocos nucifera (coconut) seed butter, hydrolyzed wheat starch, hydrolyzed wheat protein, oryzanol, phytol, camellia sinensis leaf extract, phaeodactylum tricornutum extract, tocopherol, ceteareth-20, PEG-8, polysilicone-11, stearoxytrimethylsilane, cetearyl alcohol, ceteth-2, hydrogenated lecithin, stearyl alcohol, caprylyl glycol, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, caprylic/capric triglyceride, isohexadecane, carbomer, polysorbate 60, laureth-12, tromethamine, disodium EDTA, phenoxyethanol, parfum/fragrance. - QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ANEW CLINICAL SKINVINCIBLE MULTI-SHIELD
avobenzone, homosalate, octinoxate, octocrylene, oxybenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10096-0304 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 28 mg in 1 g HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 95 mg in 1 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 75 mg in 1 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 25.6 mg in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 47.5 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10096-0304-2 1 in 1 CARTON 05/22/2013 1 NDC:10096-0304-1 30 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 2 NDC:10096-0304-4 1 in 1 CARTON 05/22/2013 2 NDC:10096-0304-3 7 g in 1 TUBE; Type 0: Not a Combination Product 3 NDC:10096-0304-5 1.1 g in 1 PACKET; Type 0: Not a Combination Product 05/22/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 05/22/2013 Labeler - New Avon LLC (080143520)
