Label: NATURAL MINERAL FORMULA- zinc oxide lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 65692-0738-1 - 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 21, 2019
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- 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
• Reapply after 80 minutes of swimming or sweating, •Reapply
• immediately after towel drying. •Reapply 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 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
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Product Package Labeling
Dist. by: Raining Rose, Inc., Cedar Rapids, IA 52403
Broad Spectrum SPF 30 Sunscreen
NATURAL MINERAL FORMULA
WATER RESISTANT
(80 MINUTES)
1.5 fl. oz. / 44 ml
L000000
Dist. by: Raining Rose Inc., Cedar Rapids, IA 52403
Broad Spectrum SPF 30 Sunscreen
NATURAL MINERAL FORMULA
Made in the USA
1.5 fl. oz. / 44 ml
L000000
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INGREDIENTS AND APPEARANCE
NATURAL MINERAL FORMULA
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65692-0738 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 8.25 g in 44 mL Inactive Ingredients Ingredient Name Strength SUNFLOWER OIL (UNII: 3W1JG795YI) YELLOW WAX (UNII: 2ZA36H0S2V) JOJOBA OIL (UNII: 724GKU717M) COCONUT OIL (UNII: Q9L0O73W7L) TOCOPHEROL (UNII: R0ZB2556P8) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65692-0738-1 44 mL in 1 TUBE; Type 0: Not a Combination Product 08/16/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 08/16/2019 Labeler - Raining Rose, Inc. (083819404) Registrant - Raining Rose, Inc. (083819404)