Label: BROAD SPECTRUM SPF50 WATER RESISTANT (80 MINUTES) MINERAL SUNSCREEN UVA UVB PROTECTION STICK FOR KIDS- zinc oxide stick
- NDC Code(s): 53675-205-00
- Packager: Aruba Aloe Balm NV
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated November 6, 2023
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- Official Label (Printer Friendly)
- Drug Facts
- Active ingredients
- Uses
- Warnings
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Directions
•apply generously 15 minutes before sun exposure. • reapply • after 80 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 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 of age: Ask a doctor.
- Other Information
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Inactive ingredients
Candelilla Wax, Caprylic/Capric Triglyceride, Cera Alba (Beeswax), Cocos Nucifera (Coconut) Oil, Myristyl Myristate, C18-20 Alkane, Butyrospermum Parkii (Shea) Butter, C13-14 Alkane, Tridecyl Salicylate, Theobroma Cacao (Cocoa) Seed Butter, Helianthus Annuus (Sunflower) Seed Wax, Tocopheryl Acetate, Fragrance (Parfum), Aloe Barbadensis Leaf Juice (Aloe Vera Gel from Aruba), Sorbitan Oleate, Simmondsia Chinensis (Jojoba) Seed Oil, Triethoxycaprylylsilane.
- Package Labeling:
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INGREDIENTS AND APPEARANCE
BROAD SPECTRUM SPF50 WATER RESISTANT (80 MINUTES) MINERAL SUNSCREEN UVA UVB PROTECTION STICK FOR KIDS
zinc oxide stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53675-205 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 200 mg in 1 mL Inactive Ingredients Ingredient Name Strength CANDELILLA WAX (UNII: WL0328HX19) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) YELLOW WAX (UNII: 2ZA36H0S2V) COCONUT OIL (UNII: Q9L0O73W7L) MYRISTYL MYRISTATE (UNII: 4042ZC00DY) SHEA BUTTER (UNII: K49155WL9Y) TRIDECYL SALICYLATE (UNII: AZQ08K38Z1) COCOA BUTTER (UNII: 512OYT1CRR) HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ALOE VERA LEAF (UNII: ZY81Z83H0X) SORBITAN MONOOLEATE (UNII: 06XEA2VD56) JOJOBA OIL (UNII: 724GKU717M) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53675-205-00 30 mL in 1 CONTAINER; Type 0: Not a Combination Product 03/08/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 03/08/2022 Labeler - Aruba Aloe Balm NV (855442273) Establishment Name Address ID/FEI Business Operations Aruba Aloe Balm NV 855442273 manufacture(53675-205)