Label: SUNFORGETTABLE BRUSH-ON SUNSCREEN SPF 30- titanium dioxide and zinc oxide powder
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Contains inactivated NDC Code(s)
NDC Code(s): 68078-021-22 - Packager: Colorescience
- 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 December 22, 2021
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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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
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Directions
- Apply liberally 15 minutes before sun exposure. Works best on moisturized skin.
- Reapply:
- After 80 minutes of swimming or sweating.
- Immediately after towel drying.
- 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 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 ingredients
- Other information
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 6 g Tube Carton
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INGREDIENTS AND APPEARANCE
SUNFORGETTABLE BRUSH-ON SUNSCREEN SPF 30
titanium dioxide and zinc oxide powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68078-021 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 210 mg in 1 g Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 118 mg in 1 g Inactive Ingredients Ingredient Name Strength Mica (UNII: V8A1AW0880) Dimethicone/Vinyl Dimethicone Crosspolymer (Soft Particle) (UNII: 9E4CO0W6C5) Phymatolithon Calcareum (UNII: 6J1M3WA0ZK) Mannitol (UNII: 3OWL53L36A) Methicone (20 CST) (UNII: 6777U11MKT) Dimethicone (UNII: 92RU3N3Y1O) Laureth-4 (UNII: 6HQ855798J) Calcium Silicate (UNII: S4255P4G5M) Triethoxycaprylylsilane (UNII: LDC331P08E) Diatomaceous Earth (UNII: 2RF6EJ0M85) Sodium Sulfate (UNII: 0YPR65R21J) Zinc Sulfate, Unspecified Form (UNII: 89DS0H96TB) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERRIC OXIDE RED (UNII: 1K09F3G675) FERROSOFERRIC OXIDE (UNII: XM0M87F357) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68078-021-22 1 in 1 CARTON 02/01/2017 1 6 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 02/01/2017 Labeler - Colorescience (128731929)