Label: FACESCREEN SPF 50- avobenzone, homosalate, octinoxate, octisalate, octocrylene,oxybenzone liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 49825-122-01, 49825-122-02 - Packager: Bioelements
- 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 March 26, 2012
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- Official Label (Printer Friendly)
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ACTIVE INGREDIENT
Active ingredients Purpose
Avobenzone 3.0% Sunscreen
Homosalate 10% Sunscreen
Octinoxate 7.0% Sunscreen
Octisalate 5.0% Sunscreen
Octocrylene 5.0% Sunscreen
Oxybenzone 6.0% 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.
Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
Warnings
For external use only
Do not use on broken or damaged skin
When using this product Keep out of eyes. Rinse with water to remove.
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: 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 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-sleeve shirts, pants, hats, and sunglasses
Acrylates/C10-30 Alyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice Powder, Angelica Polymorpha Sinensis (Dong Quai) Root Extract, Ascorbyl Palmitate, Butylene Glycol, Centella Asiatica (Gotu Kola) Extract, Cetyl Dimethicone, Chamomile Recutita (Matricaria) Flower Extract, Chlorphenesin, Disodium EDTA, Glycerin, Nastartium Officinale (Watercress) Extract, Panax Ginseng (Ginseng) Root Extract, Phenoxyethanol, Phospholipids, Retinyl Palmitate, Rhus Glabra (Sumac) Extract, Steareth-2, Steareth-21, Tocopheryl Acetate, Triethanolamine, Water (Aqua,Eau)
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INGREDIENTS AND APPEARANCE
FACESCREEN SPF 50
avobenzone, homosalate, octinoxate, octisalate, octocrylene,oxybenzone liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49825-122 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3.0 mL in 100 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 10 mL in 100 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.0 mL in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5.0 mL in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 5.0 mL in 100 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 6.0 mL in 100 mL Inactive Ingredients Ingredient Name Strength CARBOMER INTERPOLYMER TYPE A (55000 MPA.S) (UNII: 59TL3WG5CO) ALOE VERA LEAF (UNII: ZY81Z83H0X) ANGELICA SINENSIS ROOT (UNII: B66F4574UG) ASCORBYL PALMITATE (UNII: QN83US2B0N) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) CENTELLA ASIATICA (UNII: 7M867G6T1U) CHAMOMILE (UNII: FGL3685T2X) CHLORPHENESIN (UNII: I670DAL4SZ) EDETATE DISODIUM (UNII: 7FLD91C86K) GLYCERIN (UNII: PDC6A3C0OX) ASIAN GINSENG (UNII: CUQ3A77YXI) PHENOXYETHANOL (UNII: HIE492ZZ3T) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) RHUS GLABRA BARK (UNII: 7XC0E9WP6U) STEARETH-2 (UNII: V56DFE46J5) STEARETH-21 (UNII: 53J3F32P58) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) TROLAMINE (UNII: 9O3K93S3TK) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49825-122-02 1 in 1 CARTON 1 NDC:49825-122-01 68 mL in 1 JAR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 03/23/2012 Labeler - Bioelements (174813923) Registrant - Bioelements (174813923) Establishment Name Address ID/FEI Business Operations Cosmetic Enterprises 017701475 manufacture
