Label: JASON PURE NATURAL SUN MINERAL NATURAL SUNSCREEN BROAD SPECTRUM SPF30- zinc oxide, titanium oxide lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 61995-0315-4 - Packager: The Hain Celestial Group, Inc.
- 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 20, 2012
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Apply liberally 15 minutes before sun exposure. Use a water resistant sunscreen if swimming or sweating. Reapply at least every 2 hours. Children under 6 months, ask a doctor . Skin Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging.To decrease risk, regularly use a sunscreen with Broad Spectrum SPF value of 15 or higher and other protective measures including:
- Limit time in the sun, especially from 10am to 2pm
- Wear long-sleeved shirts, pants, hats and sunglasses.
- Limit time in the sun, especially from 10am to 2pm
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INACTIVE INGREDIENT
Aqua (Water), Caprylic/Capric Triglycerides, Dimethicone, Ethylhexyl Palmitate, Sorbitan Sesquioleate, Glycerin, Glyceryl Isostearate, Butyrospermum Parkii (Shea Butter), Helianthus Annuus (Sunflower) Seed Oil (1), Simmondsia Chinensis (Jojoba) Seed Oil (1), Polyglyceryl-3 Ricinoleate, Vitis Vinifera (Grape) Seed) Oil,Aloe Barbadensis Leaf Juice (1), Calendula Officinalis Flower Extract (1),Chamomilla Recutita (Matricaria ) Flower Extract (1), Camellia Sinensis Leaf Extract (1), Magnesium Sulfate, Silica, Sodium Chloride,Tocopheryl Acetate, Benzyl Alcohol, Phenoxyethanol, Polyhydroxystearic Acid.
(1) Certified Organic Ingredients
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
JASON PURE NATURAL SUN MINERAL NATURAL SUNSCREEN BROAD SPECTRUM SPF30
zinc oxide, titanium oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61995-0315 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 14.5 g in 100 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2.0 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) DIMETHICONE (UNII: 92RU3N3Y1O) ETHYLHEXYL PALMITATE (UNII: 2865993309) SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO) SHEA BUTTER (UNII: K49155WL9Y) SUNFLOWER OIL (UNII: 3W1JG795YI) JOJOBA OIL (UNII: 724GKU717M) GRAPE SEED OIL (UNII: 930MLC8XGG) ALOE VERA LEAF (UNII: ZY81Z83H0X) CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) CHAMOMILE (UNII: FGL3685T2X) GREEN TEA LEAF (UNII: W2ZU1RY8B0) MAGNESIUM SULFATE (UNII: DE08037SAB) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM CHLORIDE (UNII: 451W47IQ8X) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) BENZYL ALCOHOL (UNII: LKG8494WBH) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61995-0315-4 113 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 08/20/2011 Labeler - The Hain Celestial Group, Inc. (858894996) Establishment Name Address ID/FEI Business Operations The Hain Celestial Group, Inc. 858894996 manufacture(61995-0315)
