Label: CREAM- titanium dioxide, zinc oxide lotion
- NDC Code(s): 61354-051-17
- Packager: OXYGEN DEVELOPMENT, 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 10, 2023
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- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Uses
- Warnings
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Directions
- Shake before use.
- Apply liberally 15 minutes before sun exposure.
- Use a water-resistant sunscreen of 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 our 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.- 2p.m.
Wear long-sleeved shirts, pants, hats and sunglasses. - Other information
- Inactive Ingredients
- Primary Package (Inner)
- Secondary Package (Outer)
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INGREDIENTS AND APPEARANCE
CREAM
titanium dioxide, zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61354-051 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 3.5 mg in 100 mg TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 4.55 mg in 100 mg Inactive Ingredients Ingredient Name Strength POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK) HEXYL LAURATE (UNII: 4CG9F9W01Q) ISODODECANE (UNII: A8289P68Y2) MICA (UNII: V8A1AW0880) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) STEARIC ACID (UNII: 4ELV7Z65AP) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61354-051-17 1 in 1 CARTON 02/23/2021 1 30 mg 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 02/23/2021 Labeler - OXYGEN DEVELOPMENT, LLC (137098492) Establishment Name Address ID/FEI Business Operations OXYGEN DEVELOPMENT, LLC 137098492 manufacture(61354-051)