SEVEN MINERALS SKIN FRIENDLY SPF 30- avobenzone, octisalate, octocrylene lotion

SEVEN MINERALS Skin Friendly SPF 30 by

Drug Labeling and Warnings

SEVEN MINERALS Skin Friendly SPF 30 by is a Otc medication manufactured, distributed, or labeled by Seven Minerals NA LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS

Active Ingredients

Avobenzone 3.00%, Octisalate 5.00%, Octocrylene 5.00%

Purpose

Sunscreen

USES:

Helps prevent sunburn. Higher SPF gives more sunburn protection.  Retains SPF after 80 minutes of swimming or sweating. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin 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 or irritation develops and lasts.

Keep out of reach of children.

• If product is swallowed, get medical attention or contact poison control center immediately.

DIRECTIONS:

Apply liberally 15 minutes before sun exposure and as needed. Children under 6 months of age: ask a doctor. Reapply: after 80 minutes of swimming or sweating  immediately after towel drying at least every 2 hours.
SUN PROTECTION MEASURES: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use sunscreen with broad spectrum protection and an SPF rating of 15 or higher, along with other sun protection measures including: Limit time in the sun, especially between 10am and 2pm. Wear long sleeve shirts, pants, hats and sunglasses.

OTHER INFORMATION:

Protect this product from excessive heat and direct sunlight.

INACTIVE INGREDIENTS:

Acrylates Copolymer, *Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Amodimethicone, Aqua (Deionized Water), Bis Vinyl Dimethicone/ Dimethicone Copolymer, Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Cetearyl Olivate, Citrullus Lanatus (Watermelon) Extract, Cocos Nucifera (Coconut) Oil, Cyclopentasiloxane, Daucus Carota Sativa (Carrot) Extract, Glycerin, Glyceryl Caprylate, Glyceryl Undecylenate, Helianthus Annuus (Sunflower) Oil, Magnesium Chloride, Magnesium Sulfate, Mangifera Indica (Mango) Butter, Polysorbate-20, Sodium Hydroxide, Sorbitan Olivate, Stearic Acid, Tocopherol (Vitamin E), Zemea (Corn) Propanediol.

Package Labeling:

INGREDIENTS AND APPEARANCE

SEVEN MINERALS SKIN FRIENDLY SPF 30 
avobenzone, octisalate, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73609-220
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
WATERMELON (UNII: 231473QB6R)
COCONUT OIL (UNII: Q9L0O73W7L)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
CARROT (UNII: L56Z1JK48B)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544)
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
MANGO (UNII: I629I3NR86)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SORBITAN OLIVATE (UNII: MDL271E3GR)
STEARIC ACID (UNII: 4ELV7Z65AP)
TOCOPHEROL (UNII: R0ZB2556P8)
CORN (UNII: 0N8672707O)
PROPANEDIOL (UNII: 5965N8W85T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73609-220-08	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/03/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	02/03/2020

Labeler - Seven Minerals NA LLC (080963342)