Label: TRANSPARENT MINERAL SUNSCREEN FACESTICK BROAD SPECTRUM SPF 50- zinc oxide stick
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Contains inactivated NDC Code(s)
NDC Code(s): 71942-103-01 - Packager: Amavara, Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 May 8, 2018
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- ACTIVE INGREDIENT
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PURPOSE
Uses
- Helps Prevent Sunburn
- Higher SPF gives more sunburn protection
- 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.
- Retains SPF after 80 minutes activity in the water, sweating, or perspiring.
- Provides high Protection against sunburn.
- KEEP OUT OF REACH OF CHILDREN
- WARNINGS
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DOSAGE & ADMINISTRATION
Directions
• Apply liberally and generously 15 minutes before sun exposure and 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 your time in the sun, especially from 10
a.m. – 2 p.m. • wear long-sleeved shirts, pants, hats, and sunglasses • Reapply:
• after 80 minutes of swimming or sweating • immediately after towel drying
• at least every 2 hours. -
INACTIVE INGREDIENT
Inactive Ingredients: Butyloctyl Salicylate, Octyldodecyl Neopentanoate, Capylic/Capric Triglyceride, Silica, Ozokerite, Nylon-12, Polyethylene, Dimethicone, Hydrogenated Olive Oil, Olea Europaea (Olive) Oil Unsafonifiables, Dimethicone/Vinyl Dimethicone Crosspolymer Hydrogenated Olive Oil Unsaponifiables, Polyhydroxystearic Acid, Tribehenin, Acrylates/Dimethicone Copolymer, Disteardimonium Hectorie, Polymethyl Methacrylate, Laureth-3, Laureth-25, Helianthus Annuus (Sunflower) Seed Wax, 1,2 Hexanediol, 1,2-Octanediol, Tocopheryl Acetate, Polymethylmethacrylate, Cerium Oxide, Bisabolol, Benzylidene Dimethoxydimethylindanone, Phenethyl Alcohol, Caprylyl Glycol, Aluminum Oxide, Zingiber Officinale (Ginger) Root Extract
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
TRANSPARENT MINERAL SUNSCREEN FACESTICK BROAD SPECTRUM SPF 50
zinc oxide stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71942-103 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 22.5 g in 100 g Inactive Ingredients Ingredient Name Strength DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) CERIC OXIDE (UNII: 619G5K328Y) LEVOMENOL (UNII: 24WE03BX2T) BENZYLIDENE DIMETHOXYDIMETHYLINDANONE (UNII: 75HIF3C97L) ALUMINUM OXIDE (UNII: LMI26O6933) TRIBEHENIN (UNII: 8OC9U7TQZ0) LAURETH-3 (UNII: F32E4CB0UJ) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) CAPRYLYL GLYCOL (UNII: 00YIU5438U) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CERESIN (UNII: Q1LS2UJO3A) NYLON-12 (UNII: 446U8J075B) LOW DENSITY POLYETHYLENE (UNII: J245LN42AI) DIMETHICONE (UNII: 92RU3N3Y1O) HYDROGENATED OLIVE OIL (UNII: 53839415GI) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) PHENYLETHYL ALCOHOL (UNII: ML9LGA7468) GINGER (UNII: C5529G5JPQ) OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLES (UNII: XO45V955LT) HYDROGENATED OLIVE OIL UNSAPONIFIABLES (UNII: B8MIX97W95) LAURETH-25 (UNII: RPD53041LR) HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71942-103-01 16.8 g in 1 BOX; Type 0: Not a Combination Product 02/12/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 02/12/2018 Labeler - Amavara, Inc (079636282) Establishment Name Address ID/FEI Business Operations Northwest Cosmetic Laboratories LLC 929572014 manufacture(71942-103)
