Label: SUN SHIELD CLEAR SPF 50 BROAD SPECTRUM- zinc oxide mineral spf 50 stick
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Contains inactivated NDC Code(s)
NDC Code(s): 76150-143-25 - Packager: Bell International Laboratories, 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 January 14, 2021
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active Ingredient
- Uses
- Warnings
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Directions
- Apply liberally and evenly 15 minutes before sun exposure.
- Reapply:
- After 80 minutes of swimming or sweating.
- Immediately after towel drying
- At least every 2 hours.
- 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 borad spectrum SPF of 15 or higher and other sun protection measures including:
- Limit time in the sun, especially from 10a.m. - 2 p.m.
- Wear long-sleeved shirts, pants, hats and sunglasses.
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Inactive Ingredients
Beeswax, Bisabolol, Butyrospermum Parkii (Shea Butter), Calophyllum Tacamahaca Seed Oil, Cannabis Sativa Seed Oil, Euphorbia Cerifera (Candelilla) Wax, Jojoba Esters, Octyldodecyl Olivate, Oryza Sativa (Rice) Bran Oil, Oryzanol, Persea Gratissima (Avocado) Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Theobroma Cacao (Cocoa) Seed Butter, Tocopherol.
- Other Information
- Shadow box artwork
- stick front label
- stick back label
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INGREDIENTS AND APPEARANCE
SUN SHIELD CLEAR SPF 50 BROAD SPECTRUM
zinc oxide mineral spf 50 stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76150-143 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 17 g in 100 mL Inactive Ingredients Ingredient Name Strength YELLOW WAX (UNII: 2ZA36H0S2V) SHEA BUTTER (UNII: K49155WL9Y) CALOPHYLLUM TACAMAHACA SEED OIL (UNII: 05G85L61OE) CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S) CANDELILLA WAX (UNII: WL0328HX19) HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58) RICE BRAN OIL (UNII: LZO6K1506A) OCTYLDODECYL OLEATE (UNII: MCA43PK7MH) LEVOMENOL (UNII: 24WE03BX2T) GAMMA ORYZANOL (UNII: SST9XCL51M) AVOCADO OIL (UNII: 6VNO72PFC1) JOJOBA OIL (UNII: 724GKU717M) COCOA BUTTER (UNII: 512OYT1CRR) TOCOPHEROL (UNII: R0ZB2556P8) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76150-143-25 15 mL in 1 TUBE; Type 0: Not a Combination Product 01/01/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 01/01/2016 Labeler - Bell International Laboratories, Inc. (967781555) Registrant - Bell International Laboratories, Inc. (967781555)
