Label: SUN AND SHINE MINERAL SUNSCREEN- zinc oxide cream
- NDC Code(s): 69435-1505-1
- Packager: Peer Pharm Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 31, 2024
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- Drug Facts
- Active Ingredients
- Uses
- Warnings
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Directions
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 am to 2 p.m.
• wear long-sleeve shirts, pants, hats, and sunglasses
• Children under 6 months: ask a doctor - Other information
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Inactive Ingredients
aqua, coco-caprylate, styrene/acrylates copolymer, octyldodecyl citrate crosspolymer, cetearyl olivate, sorbitan olivate, caprylyl glycol, glycerin, polyhydroxystearic acid, aloe barbadensis leaf juice, panthenol, triethoxycaprylylsilane, cetearyl alcohol, tocopherol, butyrospermum parkii (shea) butter, silica, silica dimethyl silylate, xanthan gum, caprylhydroxamic acid, propanediol, sodium phytate, dipotassium glycyrrhizate, chamomilla recutita (matricaria) flower extract, calendula officinalis flower extract, citric acid
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INGREDIENTS AND APPEARANCE
SUN AND SHINE MINERAL SUNSCREEN
zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69435-1505 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 24.5 g in 100 mL Inactive Ingredients Ingredient Name Strength TOCOPHEROL (UNII: R0ZB2556P8) CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25) HEXASODIUM PHYTATE (UNII: ZBX50UG81V) CALENDULA OFFICINALIS SEED OIL (UNII: 9JS8DS42SV) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) SHEA BUTTER (UNII: K49155WL9Y) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) XANTHAN GUM (UNII: TTV12P4NEE) CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W) DIPOTASSIUM GLUCOSE-6-PHOSPHATE (UNII: ZZW95F4360) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) CAPRYLYL GLYCOL (UNII: 00YIU5438U) COCO-CAPRYLATE (UNII: 4828G836N6) SODIUM ACRYLATE/STYRENE SULFONATE COPOLYMER (11000 MW) (UNII: N30934870L) ISOBUTANE (UNII: BXR49TP611) WATER (UNII: 059QF0KO0R) 1-(ETHYLTRISULFANYL)PROPANE (UNII: 4SOS6O9G2X) TRIOCTYLDODECYL CITRATE (UNII: 35X8CT063R) ACRYLATES CROSSPOLYMER-4 (UNII: GEV2EL4D9G) CETEARYL OLIVATE (UNII: 58B69Q84JO) SORBITAN OLIVATE (UNII: MDL271E3GR) CASTOR OIL (UNII: D5340Y2I9G) GLYCERIN (UNII: PDC6A3C0OX) PROPANEDIOL 1-PHOSPHATE (UNII: 48G71659RB) CHAMOMILE (UNII: FGL3685T2X) PANTHENOL (UNII: WV9CM0O67Z) ALOE (UNII: V5VD430YW9) 1,4-BUTANEDITHIOL (UNII: 7JD227IUMC) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69435-1505-1 1 in 1 CARTON 05/19/2022 1 50 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 05/19/2022 Labeler - Peer Pharm Ltd. (514678390) Registrant - Peer Pharm Ltd. (514678390) Establishment Name Address ID/FEI Business Operations Peer Pharm Ltd. 514678390 manufacture(69435-1505)
