Label: SHEER DAILY WEAR FACE PROTECTION MINERAL BASED SUNSCREEN SPF 16- zinc oxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 82328-0012-0 - Packager: REJUVA MINERALS INC
- 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 October 13, 2021
If you are a consumer or patient please visit this version.
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- Drug Facts
- Active Ingredients
- Uses:
- Warnings:
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Directions:
Apply liberally 15 minutes before sun exposure
- Reapply 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 value of SPF 15 or higher and other sun protection measures including: limit time in the sun, especially from 10a.m. – 2p.m.
- Wear long-sleeved shirts, pants, hats, and sunglasses
- use water resistant sunscreen if swimming or sweating
- Children under 6 months of age: Ask a doctor.
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Inactive Ingredients:
Water (Aqua), Caprylic/Capric Triglyceride, Helianthus Annuus (Sunflower) Oil, Cocos Nucifera (Coconut) Oil, Sorbitan Stearate, Polyglyceryl-10 Laurate, Glycerin*, Polyhydroxystearic Acid, Aloe Barbadensis Leaf Juice, Magnesium Sulfate, Gluconolactone, Triethoxycaprylylsilane, Sodium Benzoate, Santalum Album (Sandalwood) Oil, Glycerin, Xanthan Gum, Simmondsia Chinensis (Jojoba) Seed Oil*, Helianthus Annuus (Sunflower) Seed Oil*, Cocos Nucifera (Virgin Coconut) Oil*, Calcium Gluconate, Sodium Hyaluronate, Palmitoyl Tetrapeptide-7, Palmitoyl Hexapeptide-12. *Certified Organic. May Contain: Iron Oxide CI 77492, Iron Oxide CI 77491, Iron Oxide CI 77499
- Questions:
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INGREDIENTS AND APPEARANCE
SHEER DAILY WEAR FACE PROTECTION MINERAL BASED SUNSCREEN SPF 16
zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82328-0012 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 175 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP) COCONUT OIL (UNII: Q9L0O73W7L) SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X) POLYGLYCERYL-10 LAURATE (UNII: MPJ2Q8WI8G) GLYCERIN (UNII: PDC6A3C0OX) ALOE VERA LEAF (UNII: ZY81Z83H0X) MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB) GLUCONOLACTONE (UNII: WQ29KQ9POT) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) SODIUM BENZOATE (UNII: OJ245FE5EU) SANDALWOOD OIL (UNII: X7X01WMQ5F) XANTHAN GUM (UNII: TTV12P4NEE) JOJOBA OIL (UNII: 724GKU717M) SUNFLOWER OIL (UNII: 3W1JG795YI) CALCIUM GLUCONATE (UNII: SQE6VB453K) HYALURONATE SODIUM (UNII: YSE9PPT4TH) PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R) PALMITOYL HEXAPEPTIDE-12 (UNII: HO4ZT5S86C) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82328-0012-0 50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 11/01/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 11/01/2021 Labeler - REJUVA MINERALS INC (014406614) Establishment Name Address ID/FEI Business Operations Columbia Cosmetics Manufacturing, Inc. 068267863 manufacture(82328-0012)
