NATIVE MINERAL SUNSCREEN BROAD SPECTRUM SPF 30 TROPICAL BREEZE - TWINCRAFT- zinc oxide lotion

Native Mineral Sunscreen Broad Spectrum SPF 30 Tropical Breeze - Twincraft by

Drug Labeling and Warnings

Native Mineral Sunscreen Broad Spectrum SPF 30 Tropical Breeze - Twincraft by is a Otc medication manufactured, distributed, or labeled by Twincraft Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

ZINC OXIDE 20%

Sunscreen

Uses

• helps prevent sunburn
• 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 occurs

Keep out of reach of children.If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

• apply liberally 15 minutes before sun exposure
• reapply at least every 2 hours
• use water resistant sunscreen if swimming or sweating
• Sun Protection Measures.Spending 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 SPF value of 15 or higher and other sun protection measures including:
  • limit time in sun, especially from 10 a.m. – 2 p.m.
  • wear long-sleeved shirts, pants, hats, and sunglasses
• children under 6 months: ask a doctor

Other information

• protect this product from excessive heat and direct sun

Inactive ingredients

water, caprylic/capric triglyceride, coconut alkanes, glycerin, cetearyl alcohol, coco-glucoside, arachidyl alcohol, behenyl alcohol, arachidyl glucoside, polyhydroxystearic acid, benzyl alcohol, xanthan gum, coco-caprylate/caprate, fragrance, tocopherol, helianthus annuus (sunflower) seed oil

SPL UNCLASSIFIED SECTION

Distr. by Native San Francisco, CA 94111

Questions or comments?

Please contact support@nativecos.com

PRINCIPAL DISPLAY PANEL - 147 mL Tube

BROAD SPECTRUM SPF 30

MINERAL SUNCARE

ZINC OXIDE SUNSCREEN

NATIVE

TROPICAL BREEZE

NO OXYBENZONE

NO OCTINOXATE

5 FL OZ (147 mL)

INGREDIENTS AND APPEARANCE

NATIVE MINERAL SUNSCREEN BROAD SPECTRUM SPF 30 TROPICAL BREEZE - TWINCRAFT 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64412-5001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	20 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
COCONUT ALKANES (UNII: 1E5KJY107T)
COCO GLUCOSIDE (UNII: ICS790225B)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
TOCOPHEROL (UNII: R0ZB2556P8)
DOCOSANOL (UNII: 9G1OE216XY)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
SUNFLOWER OIL (UNII: 3W1JG795YI)
BENZYL ALCOHOL (UNII: LKG8494WBH)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64412-5001-1	147 mL in 1 TUBE; Type 0: Not a Combination Product	10/28/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	10/28/2024

Labeler - Twincraft Inc. (093248870)