Label: BROAD SPECTRUM SUNSCREEN SPF 30- titanium dioxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 69146-301-01, 69146-301-02 - Packager: TRUTH AESTHETICS LLC
- 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 February 8, 2018
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Back Panel - Active Ingredient
- Back Panel - Purpose
- Back Panel - Uses
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Back Panel - Directions
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
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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 board 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
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BOXED WARNING
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Back Panel - Warnings
Warnings
For external use only.
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Do not use
on damaged or broken skin
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When using this product
keep out of eyes. Rinse with water to remove.
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Stop use and ask doctor
if rash occurs
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Keep out of reach of children.
If product is swallowed, get medical help or
contact a Poison Control Center right away.
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Back Panel - Inactive Ingredients
Inactive Ingredients: Water/Aqua/EAU, Glycerin, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Cyclopentasiloxane, coconut Alkanes, Caprylic / Capric Triglycerine, Mica (CI77019), Propanediol, Polyhydroxystearic Acid, Stearoxymethicone / Dimenthicone Copolymer, Stearic Acid, Simmondsia Chinensis (Jojoba) Seed Oil, Diisopropyl Dimer Dilinoleate, Alumina, Caprylyl Caprylate / Caprate, Lauryl Glucoside, Phenethyl Alcohol, Oriza Sativa (Rice) Bran Extract, Pyrus Malus (Apple) Fruit Extract, Coco- Caprylate / Caprate, Cichorium Intybus (Chicory) Root Extract, Carbomer, Helianthus Annuus (Sunflower) Seed Oil, Ethylhexylglycerin, Aminomethyl Propanol, Xanthan Gum, Phenoxyethanol, Silica, Rosmarinus Officinalis (Rosemary) Leaf Extract, Tocopherol.
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- Front Panel - PDP
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INGREDIENTS AND APPEARANCE
BROAD SPECTRUM SUNSCREEN SPF 30
titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69146-301 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 12.1 mg in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) COCONUT ALKANES (UNII: 1E5KJY107T) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) MICA (UNII: V8A1AW0880) PROPANEDIOL (UNII: 5965N8W85T) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) STEARIC ACID (UNII: 4ELV7Z65AP) JOJOBA OIL (UNII: 724GKU717M) DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR) ALUMINUM OXIDE (UNII: LMI26O6933) CAPRYLYL CAPRYLATE/CAPRATE (UNII: 22MCG4RSMR) LAURYL GLUCOSIDE (UNII: 76LN7P7UCU) PHENYLETHYL ALCOHOL (UNII: ML9LGA7468) RICE BRAN (UNII: R60QEP13IC) APPLE (UNII: B423VGH5S9) FERRIC OXIDE RED (UNII: 1K09F3G675) COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H) CHICORY ROOT (UNII: 090CTY533N) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) SUNFLOWER OIL (UNII: 3W1JG795YI) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) AMINOMETHYLPROPANOL (UNII: LU49E6626Q) XANTHAN GUM (UNII: TTV12P4NEE) PHENOXYETHANOL (UNII: HIE492ZZ3T) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) ROSEMARY (UNII: IJ67X351P9) TOCOPHEROL (UNII: R0ZB2556P8) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69146-301-02 1 in 1 BOX 03/01/2015 1 NDC:69146-301-01 30 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 03/01/2015 Labeler - TRUTH AESTHETICS LLC (025362874)
