Label: 100% PURE SWEET MINT LIP BALM SPF 15- zinc oxide stick
Contains inactivated NDC Code(s)
NDC Code(s): 52667-005-01
- Packager: Purity Cosmetics
- Category: HUMAN OTC DRUG LABEL
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 May 1, 2017
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- Active Ingredients
- WHEN USING
- KEEP OUT OF REACH OF CHILDREN
- Apply liberally 15 minutes before sun exposure.
- Reapply: after 40 minutes of swimming or sweating / immediately after towel drying / at least every 2 hours
- 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 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.
- Children under 6 months: Ask a doctor.
*Cerba Alba (Beeswax), Fair Trade Certified™ *Theobroma Cacao (Cocoa) Seed Butter, *Cocos Nucifera (Coconut) Oil, *Rincus Communis (Castor) Seed Oil, * Vanilla Flavor, *Helianthus Annus (Sunflower) Seed Oil, *Persea Gratissima (Avocado) Oil, Mixed Tocopherols (Vitamin E), *Mentha Piperita (Peppermint) Essential Oil, Calophyllum Inophyllum (Tamanu) Oil, Hippophae Rhamnoides (Sea Buckthorn) Fruit Oil, Calendula Officinalis (Calendula) Extract. *Certified Organic
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- 100% Pure Sweet Mint Lip Balm SPF 15
INGREDIENTS AND APPEARANCE
100% PURE SWEET MINT LIP BALM SPF 15
zinc oxide stick
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52667-005 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 87 mg in 1 g Inactive Ingredients Ingredient Name Strength SUNFLOWER OIL (UNII: 3W1JG795YI) YELLOW WAX (UNII: 2ZA36H0S2V) CASTOR OIL (UNII: D5340Y2I9G) COCOA BUTTER (UNII: 512OYT1CRR) AVOCADO OIL (UNII: 6VNO72PFC1) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) ARGAN OIL (UNII: 4V59G5UW9X) CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) TAMANU OIL (UNII: JT3LVK84A1) ALOE VERA LEAF (UNII: ZY81Z83H0X) MENTHA PIPERITA (UNII: 79M2M2UDA9) HIPPOPHAE RHAMNOIDES FRUIT OIL (UNII: TA4JCF9S1J) COCONUT OIL (UNII: Q9L0O73W7L) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52667-005-01 4.25 g in 1 TUBE; Type 0: Not a Combination Product 05/01/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 05/01/2017 Labeler - Purity Cosmetics (055795259) Establishment Name Address ID/FEI Business Operations Eco Lips, Inc. 138732727 manufacture(52667-005)