SKIN BY SCOTTIE BEACH MODE MINERAL SUNSCREEN ROLL-ON SPF 30- titanium dioxide, zinc oxide cream

Skin by Scottie Beach Mode Mineral Sunscreen Roll-On SPF 30 by

Drug Labeling and Warnings

Skin by Scottie Beach Mode Mineral Sunscreen Roll-On SPF 30 by is a Otc medication manufactured, distributed, or labeled by SKIN CARE BY SCOTTIE LLC, Pure Source, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Titanium Dioxide 6.20 %
Zinc Oxide 6.00 %

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 swallowed, get medical help or contact a Poison Control Center right away.

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 the risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other sun protection measures including:
• Limit time in the sun, especially from 10 a.m. - 2 p.m. 
• Wear long-sleeved shirts, pants, hats, and sunglasses.

Other Information

• Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Camellia Sinensis Leaf Extract, Caprylic/Capric Triglyceride, Caprylyl Glycol, Caprylyl/Capryl Glucoside, Carthamus Tinctorius (Safflower) Seed Oil, Decyl Alcohol, Ethylhexylglycerin, Glycerin, Glyceryl Stearate Citrate, Helianthus Annuus (Sunflower) Seed Oil, Hexylene Glycol, Lecithin, Leuconostoc Ferment Filtrate, Oryza Sativa (Rice) Extract, Phenoxyethanol, Polyhydroxystearic Acid, Potassium Sorbate, Punica Granatum Extract, Soybean Peroxidase, Stearic Acid, Superoxide Dismutase, Theobroma Cacao (Cocoa) Seed Butter, Tocopherol, Water (Aqua), Xanthan Gum

Package Labeling:

INGREDIENTS AND APPEARANCE

SKIN BY SCOTTIE BEACH MODE MINERAL SUNSCREEN ROLL-ON SPF 30 
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85807-616
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (CI 77891 - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	62 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	60 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF JUICE (UNII: RUE8E6T4NB)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CAPRYLYL/CAPRYL GLUCOSIDE (UNII: E00JL9G9K0)
SAFFLOWER OIL (UNII: 65UEH262IS)
DECYL ALCOHOL (UNII: 89V4LX791F)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)
SUNFLOWER OIL (UNII: 3W1JG795YI)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
RICE GERM (UNII: 7N2B70SFEZ)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D)
STEARIC ACID (UNII: 4ELV7Z65AP)
SUPEROXIDE DISMUTASE (UNII: W2T4YRA9AD)
COCOA BUTTER (UNII: 512OYT1CRR)
TOCOPHEROL (UNII: R0ZB2556P8)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85807-616-00	89 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	05/29/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	05/29/2025

Labeler - SKIN CARE BY SCOTTIE LLC (131918171)

Registrant - Pure Source, LLC (080354456)