Label: SPF 30 MINERAL SUN STICK- zinc oxide stick
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Contains inactivated NDC Code(s)
NDC Code(s): 65692-0848-1 - Packager: Raining Rose, 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 August 23, 2019
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Purpose
- Uses
- WARNINGS
- DO NOT USE
- STOP USE
- WHEN USING
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
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 of age: Ask a doctorSun 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 protection measures including:
• limit time in the sun, especially from 10a.m. - 2p.m.
• wear long sleeved shirts, pants, hat, and sunglasses. - INACTIVE INGREDIENT
- OTHER SAFETY INFORMATION
- Product Package Labeling
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INGREDIENTS AND APPEARANCE
SPF 30 MINERAL SUN STICK
zinc oxide stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65692-0848 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 3.06 g in 17 g Inactive Ingredients Ingredient Name Strength SUNFLOWER OIL (UNII: 3W1JG795YI) YELLOW WAX (UNII: 2ZA36H0S2V) OLIVE OIL (UNII: 6UYK2W1W1E) TOCOPHEROL (UNII: R0ZB2556P8) ALOE VERA LEAF (UNII: ZY81Z83H0X) CANOLA OIL (UNII: 331KBJ17RK) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65692-0848-1 17 g in 1 TUBE; Type 0: Not a Combination Product 08/21/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 08/21/2019 Labeler - Raining Rose, Inc. (083819404) Registrant - Raining Rose, Inc. (083819404)