Label: SQUALANE ZINC SHEER MINERAL SUNSCREEN cream
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Contains inactivated NDC Code(s)
NDC Code(s): 73517-125-01 - Packager: Amyris, 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 January 7, 2022
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- Purpose
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Uses
Warnings
Directions
Helps prevent sunburn
if used as directed with other sun protection measures (see directions), decreases the risk of skin cancer and early signs of aging caused by the sun
Warnings
For external use only
Do not use on damaged or broken skin
When using this product keep out of eyes Rinse with water to remove
Stop use and ask a doctor if rash occurs
Keep out of reach of children if product is swallwed get medical help or contact Poison Control Center right away
Directions
apply generously 15 minutes before sun exposure. reapply at least every 2 hours
Sun Protection Measures
Spendign 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 value of SPF 15 or higher and other sun protections measures including: limit time in the sun, especially from 10 am - 2pm
wear long-sleeved shirts, pants, hats, and sunglasses
use a water resistant sunscreen if swimming or sweating
children under 6 months of age ask a doctor.
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Inactive Ingredients:
Inactive Ingredients: Water, Caprylic/Capric Triglyceride, Squalane, Glycerin, Cetearyl Alcohol, Methyl Dihydroabietate, Sorbitan Olivate, Coco-Glucoside, Cetyl Palmitate, Polyglyceryl-3 Polyricinoleate, Caprylyl/Capryl Glucoside, Nymphaea Alba Flower Extract, Acacia Senegal Gum, Ethyl Ferulate, Xanthan Gum, Sodium Gluconate, Lecithin, Sodium Palmitoyl Proline, Polyhydroxystearic Acid, Ethylhexylglycerin, Phenoxyethanol, Isostearic Acid.
- QUESTIONS
- Other Information
- 50 mL NDC 73517-125-01
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INGREDIENTS AND APPEARANCE
SQUALANE ZINC SHEER MINERAL SUNSCREEN
squalane zinc sheer mineral sunscreen creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73517-125 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 mL Inactive Ingredients Ingredient Name Strength XANTHAN GUM (UNII: TTV12P4NEE) CETYL PALMITATE (UNII: 5ZA2S6B08X) NYMPHAEA ALBA FLOWER (UNII: 40KQ7Q535O) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM PALMITOYL PROLINE (UNII: 64L053FRFO) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) COCO GLUCOSIDE (UNII: ICS790225B) POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W) SQUALANE (UNII: GW89575KF9) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) SODIUM GLUCONATE (UNII: R6Q3791S76) CAPRYLYL/CAPRYL OLIGOGLUCOSIDE (UNII: E00JL9G9K0) GLYCERIN (UNII: PDC6A3C0OX) ETHYL FERULATE (UNII: 5B8915UELW) ISOSTEARIC ACID (UNII: X33R8U0062) ACACIA (UNII: 5C5403N26O) WATER (UNII: 059QF0KO0R) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) SORBITAN OLIVATE (UNII: MDL271E3GR) METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F) LECITHIN, SUNFLOWER (UNII: 834K0WOS5G) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73517-125-01 50 mL in 1 TUBE; Type 0: Not a Combination Product 04/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 04/01/2020 Labeler - Amyris, Inc (185930182)
