Label: BROAD SPECTRUM SPF 15 COCONUT LIP BALM- zinc oxide stick
- NDC Code(s): 65692-0307-1
- 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 April 27, 2021
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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
-
DOSAGE & ADMINISTRATION
Directions Apply liberally 15 minutes before sun exposure •
• Use a water resistant sunscreen if swimming or sweatinb •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, hats and sunglasses. - INACTIVE INGREDIENT
- SPL UNCLASSIFIED SECTION
- Product Package Labeling
-
INGREDIENTS AND APPEARANCE
BROAD SPECTRUM SPF 15 COCONUT LIP BALM
zinc oxide stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65692-0307 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 35 mg in 1 g Inactive Ingredients Ingredient Name Strength CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) COMFREY LEAF (UNII: DG4F8T839X) LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M) PLANTAGO MAJOR LEAF (UNII: 7DC28K241X) ACHILLEA MILLEFOLIUM FLOWER (UNII: YQR8R0SQEA) OLIVE OIL (UNII: 6UYK2W1W1E) YELLOW WAX (UNII: 2ZA36H0S2V) TOCOPHEROL (UNII: R0ZB2556P8) Product Characteristics Color Score Shape Size Flavor COCONUT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65692-0307-1 4.25 g in 1 TUBE; Type 0: Not a Combination Product 04/27/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 04/27/2021 Labeler - Raining Rose, Inc. (083819404) Registrant - Raining Rose, Inc. (083819404)