Label: KIDS AND BABY ORGANIC SUNSCREEN- zinc oxide lotion
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- NDC Code(s): 71330-102-90
- Packager: ALTEYA ORGANICS OOD
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 13, 2021
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- Drug Facts
- Active Ingredient:
- Purpose
- INDICATIONS & USAGE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Directions: • Apply generously (2mg /cm2 of skin) 15 minutes before sun exposure. • Reapply after 40 minutes of swimming or sweating, immediately after towel drying, at least every 2 hours. • For Children under 6 months: 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 15 or higher and other sun protection measures including: • limit time in the sun, especially from 10 a.m. - 2 p.m. • wear long- sleeve shirts, pants, hats and sunglasses.
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INACTIVE INGREDIENT
Inactive Ingredients: Simmondsia Chinensis (Jojoba) Seed Oil*, Helianthus Annuus (Sunflower) Seed Oil*, Calendula Officinalis (Calendula) Flower Oil*, Cera Alba (Beeswax)*, Butyrospermum Parkii (Shea Butter)*, Copernicia Cerifera (Carnauba) Wax*, Carthamus Tinctorius Seed Oil / Safflower Acid, Isoamyl Laurate, Caprylic/Capric Triglycerides, Macadamia Integrifolia (Macadamia) Oil*, Cocos Nucifera (Coconut) Oil*, Persea Gratissima (Avocado) Oil*, Theobroma Cacao (Cocoa) Butter*, Lavandula Angustifolia (Lavender) Oil*, Anthemis Nobilis (Roman Chamomile) Flower Oil*, Calendula Officinalis (Flower) Extract*, Hippophae Rhamnoides (Seabuckthorn) Fruit Extract*, Iron Oxides (CI 77492, CI 77491, CI 77499), Tocopherol (Vitamin E).
* Certified Organic Ingredients
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INGREDIENTS AND APPEARANCE
KIDS AND BABY ORGANIC SUNSCREEN
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71330-102 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 20 g in 100 mL Inactive Ingredients Ingredient Name Strength JOJOBA OIL (UNII: 724GKU717M) SUNFLOWER OIL (UNII: 3W1JG795YI) CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) YELLOW WAX (UNII: 2ZA36H0S2V) SHEA BUTTER (UNII: K49155WL9Y) CARNAUBA WAX (UNII: R12CBM0EIZ) SAFFLOWER OIL (UNII: 65UEH262IS) SAFFLOWER ACID (UNII: Y788KS82OV) ISOAMYL LAURATE (UNII: M1SLX00M3M) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) MACADAMIA OIL (UNII: 515610SU8C) COCONUT OIL (UNII: Q9L0O73W7L) AVOCADO OIL (UNII: 6VNO72PFC1) COCOA BUTTER (UNII: 512OYT1CRR) LAVENDER OIL (UNII: ZBP1YXW0H8) CHAMAEMELUM NOBILE FLOWER OIL (UNII: UB27587839) HIPPOPHAE RHAMNOIDES FRUIT (UNII: AVL0R9111T) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) FERRIC OXIDE RED (UNII: 1K09F3G675) TOCOPHEROL (UNII: R0ZB2556P8) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71330-102-90 90 mL in 1 TUBE; Type 0: Not a Combination Product 04/01/2017 04/30/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 04/01/2017 04/30/2021 Labeler - ALTEYA ORGANICS OOD (503572407) Establishment Name Address ID/FEI Business Operations ALTEYA ORGANICS OOD 503572407 manufacture(71330-102)
