Label: KIDS MINERAL SUNSCREEN SPF50- sunscreen spray
- NDC Code(s): 73418-105-05
- Packager: Hello Bello
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 September 13, 2023
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredients
- Purpose
- Uses
- Warnings
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Directions
- Shake well before use
- Apply liberally and spread evenly by hand 15 minutes before sun exposure
- Hold 4 to 6 inches away from body when spraying
- For children under 6 months of age, ask a doctor
- Do not spray directly on face
- Spray on hand and apply to face. Use in well-ventilated areas. Do not apply in wind conditions.
- Reapply: • after 80 minutes of swimming or sweating • immediately after towel use • at least every 2 hours
- Sun Protection Measures: Spending time in the sun can increase your risk of skin cancer and early skin aging. To decrease this risk, regularly use sunscreen with a Broad Spectrum SPF value of 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
- Other Information
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Inactive Ingredients
Water (Aqua), Butyloctyl Salicylate, Isononyl Isnonanoate, Dicaprylyl Carbonate, Methyl Dihydroabietate, Propanediol, Isocetyl Stearoyl Stearate, Cetearyl Alcohol, Sodium Stearoyl Glutamate, Polyester-8, C18-21 Alkane, Silica, Alumina, Tocopherol, Bisabolol, Polyhydroxystearic Acid, Coco-Glucoside, Glycerin, Caprylyl Glycol, Caprylhydroxamic Acid, Musa Sapientum (Banana) Fruit Extract, Sodium Gluconate, Citric Acid, Aloe Barbadensis Leaf Juice, Bentonite, Microcrystalline Cellulose, Cellulose Gum
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
KIDS MINERAL SUNSCREEN SPF50
sunscreen sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73418-105 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 160 mg in 1 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 34 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ISONONYL ISONONANOATE (UNII: S4V5BS6GCX) POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P) ISOCETYL STEAROYL STEARATE (UNII: IJV4LS383R) C18-C21 ALKANE (UNII: 33822S0M40) DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F) SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) ALUMINUM OXIDE (UNII: LMI26O6933) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) LEVOMENOL (UNII: 24WE03BX2T) POLYHYDROXYSTEARIC ACID STEARATE (UNII: 8KQ7I65XZE) SODIUM GLUCONATE (UNII: R6Q3791S76) TOCOPHEROL (UNII: R0ZB2556P8) GLYCERIN (UNII: PDC6A3C0OX) CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W) ALOE VERA LEAF (UNII: ZY81Z83H0X) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CAPRYLYL GLYCOL (UNII: 00YIU5438U) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) PROPANEDIOL (UNII: 5965N8W85T) COCO GLUCOSIDE (UNII: ICS790225B) BANANA (UNII: 4AJZ4765R9) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73418-105-05 142 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 09/13/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M020 09/13/2023 Labeler - Hello Bello (081135707) Establishment Name Address ID/FEI Business Operations Bell International Laboratories, Incorporated 967781555 manufacture(73418-105)
