Label: SHIMMERY SUN- octinoxate titanium dioxide lotion
- NDC Code(s): 35192-012-02
- Packager: CA-BOTANA INTERNATIONAL
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 12, 2023
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- WARNINGS
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DOSAGE & ADMINISTRATION
Helps prevent sunburn. If used as directed with other sun protection measured decreases the risk of skin cancer and early skin aging caused by the sun. Apply liberally 15 minutes before sun exposure. Use a water resistant sunscreen if swimming or sweating. Reapply: at least 2 hours. Children under 6 months: Ask a doctor. Sun protection measurements. 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 a.m - 2 p.m. Wear long-sleeve shirts, pants, hats, and sunglasses. Protect this product from excessive heat and direct sun
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INACTIVE INGREDIENT
ALANINE, ALOE VERA LEAF, ARGININE, ASCORBIC ACID, ASCORBYL PALMITATE, .ALPHA.-BISABOLOL, (+/-)-,CAPRYLIC/CAPRIC MONO/DIGLYCERIDES, CETEARYL ISONONANOATE, CETYL ALCOHOL, CITRIC ACID MONOHYDRATE, COCONUT, ETHYLHEXYLGLYCERIN, GLYCERIN, GLYCERYL MONOSTEARATE, GLYCINE, SUNFLOWER OIL, MICA, NIACIN, OLEA EUROPAEA LEAF, PANTHENOL, PHENOXYETHANOL, LECITHIN, SOYBEAN, POTASSIUM SORBATE, SODIUM PYROPHOSPHATE, PENTYLENE GLYCOL, PROPANEDIOL, ALMOND OIL, ROSA MOSCHATA OIL, ROSEMARY, HYALURONATE SODIUM, SODIUM CITRATE, SORBITAN, TOCOPHEROL, UREA, GRAPE SEED OIL, XANTHAN GUM, WATER
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- ACTIVE INGREDIENT
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INDICATIONS & USAGE
Helps prevent sunburn. If used as directed with other sun protection measured decreases the risk of skin cancer and early skin aging caused by the sun. Apply liberally 15 minutes before sun exposure. Use a water resistant sunscreen if swimming or sweating. Reapply: at least 2 hours. Children under 6 months: Ask a doctor. Sun protection measurements. 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 a.m - 2 p.m. Wear long-sleeve shirts, pants, hats, and sunglasses. Protect this product from excessive heat and direct sun
- Package label principal display panel
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INGREDIENTS AND APPEARANCE
SHIMMERY SUN
octinoxate titanium dioxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:35192-012 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 4.536 g in 113.4 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 5.67 g in 113.4 g Inactive Ingredients Ingredient Name Strength OLEA EUROPAEA LEAF (UNII: MJ95C3OH47) PANTHENOL (UNII: WV9CM0O67Z) PHENOXYETHANOL (UNII: HIE492ZZ3T) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) SODIUM PYROPHOSPHATE (UNII: O352864B8Z) PENTYLENE GLYCOL (UNII: 50C1307PZG) PROPANEDIOL (UNII: 5965N8W85T) ALMOND OIL (UNII: 66YXD4DKO9) ROSA MOSCHATA OIL (UNII: J99W255AWF) ROSEMARY (UNII: IJ67X351P9) HYALURONATE SODIUM (UNII: YSE9PPT4TH) SODIUM CITRATE (UNII: 1Q73Q2JULR) SORBITAN (UNII: 6O92ICV9RU) TOCOPHEROL (UNII: R0ZB2556P8) UREA (UNII: 8W8T17847W) GRAPE SEED OIL (UNII: 930MLC8XGG) XANTHAN GUM (UNII: TTV12P4NEE) WATER (UNII: 059QF0KO0R) ALANINE (UNII: OF5P57N2ZX) ALOE VERA LEAF (UNII: ZY81Z83H0X) ARGININE (UNII: 94ZLA3W45F) ASCORBIC ACID (UNII: PQ6CK8PD0R) ASCORBYL PALMITATE (UNII: QN83US2B0N) .ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC) CAPRYLIC/CAPRIC MONO/DIGLYCERIDES (UNII: U72Q2I8C85) CETEARYL ISONONANOATE (UNII: P5O01U99NI) CETYL ALCOHOL (UNII: 936JST6JCN) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) COCONUT (UNII: 3RT3536DHY) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) GLYCINE (UNII: TE7660XO1C) SUNFLOWER OIL (UNII: 3W1JG795YI) MICA (UNII: V8A1AW0880) NIACIN (UNII: 2679MF687A) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:35192-012-02 113.4 g in 1 TUBE; Type 0: Not a Combination Product 11/07/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 06/01/2012 Labeler - CA-BOTANA INTERNATIONAL (106276728) Registrant - RODOLFO UGELSTAD (106276728) Establishment Name Address ID/FEI Business Operations CA-BOTANA INTERNATIONAL 106276728 manufacture(35192-012)
