Label: MINERAL SUNSCREEN SPF30- zinc oxide spray
- NDC Code(s): 73418-104-05
- 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 30, 2023
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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 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 and avoid breathing mist
- Spray on hand and apply to face. Use in well-ventilated areas
- 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
- Reapply:
- • after 80 minutes of swimming or sweating
- • immediately after towel use
- • at least every 2 hours
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Inactive Ingredients
Aloe Barbadensis Leaf Juice, Butyloctyl Salicylate, Camellia Sinensis (Green Tea) Leaf Extract, Caprylhydroxamic Acid, Glyceryl Caprylate, Glycerin, Caprylic/Capric Triglycerides, Chamomilla Recutita (Matricaria) Flower Extract, Citric Acid, Coco-Caprylate, Fragrance, Glyceryl Oleate Citrate, Methylheptyl Isostearate, Pentylene Glycol, Polyhydroxystearic Acid, Sodium Chloride, Sorbitan Oleate, Tocopheryl Acetate, Water
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MINERAL SUNSCREEN SPF30
zinc oxide sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73418-104 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 140 mg in 1 g Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) PENTYLENE GLYCOL (UNII: 50C1307PZG) GLYCERYL MONOOLEATE CITRATE (UNII: NLE5KIG74K) POLYHYDROXYSTEARIC ACID STEARATE (UNII: 8KQ7I65XZE) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) WATER (UNII: 059QF0KO0R) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) GREEN TEA LEAF (UNII: W2ZU1RY8B0) GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A) SORBITAN MONOOLEATE (UNII: 06XEA2VD56) CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W) CHAMOMILE (UNII: FGL3685T2X) SODIUM CHLORIDE (UNII: 451W47IQ8X) METHYLHEPTYL ISOSTEARATE (UNII: 981F40Q9FF) COCO-CAPRYLATE (UNII: 4828G836N6) ALOE VERA LEAF (UNII: ZY81Z83H0X) GLYCERIN (UNII: PDC6A3C0OX) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73418-104-05 142 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 09/30/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M020 09/30/2023 Labeler - Hello Bello (081135707)
