SQUALANE ZINC SHEER MINERAL SUNSCREEN cream

SQUALANE ZINC SHEER MINERAL SUNSCREEN by

Drug Labeling and Warnings

SQUALANE ZINC SHEER MINERAL SUNSCREEN by is a Otc medication manufactured, distributed, or labeled by Amyris, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Purpose

Zinc Oxide 14% Sunscreen

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.

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

protect this product from excessive heat and direct sun

50 mL NDC:

73517-125-01

INGREDIENTS AND APPEARANCE

SQUALANE ZINC SHEER MINERAL SUNSCREEN 
squalane zinc sheer mineral sunscreen cream

Product 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
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
SORBITAN OLIVATE (UNII: MDL271E3GR)
METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
XANTHAN GUM (UNII: TTV12P4NEE)
CETYL PALMITATE (UNII: 5ZA2S6B08X)
NYMPHAEA ALBA FLOWER (UNII: 40KQ7Q535O)
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)

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)