HAWAIIAN TROPIC MINERAL SUNSCREEN BROAD SPECTRUM SPF 30- titanium dioxide,zinc oxide lotion
Edgewell Personal Care Brands LLC

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.

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Active Ingredients

Titanium Dioxide 4.3%, Zinc Oxide 6.0%

Purpose

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

May stain some fabrics

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

Shake well • apply liberally 15 minutes before sun exposure • 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 a sunscreen with a broad spectrum SPF value 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 • children under 6 months: Ask a doctor

Inactive ingredients

Water, C12-15 Alkyl Benzoate, Glycerin, Caprylic/Capric Triglyceride, Cetyl PEG/PPG-10/1 Dimethicone, Dimethicone, Lauryl PEG-8 Dimethicone, VP/Eicosene Copolymer, Sodium Chloride, Cocos Nucifera (Coconut) Oil, Alcohol Denat., Polyhydroxystearic Acid, Glyceryl Stearate, Phenoxyethanol, Stearalkonium Bentonite, Caprylyl Glycol, Fragrance, Alumina, Propylene Carbonate, Aleurites Moluccanus Seed Oil, Ethylhexylglycerin, Triethoxycaprylylsilane, Mica, Mineral Oil, Psidium Guajava Fruit Extract, Plumeria Acutifolia Flower Extract, Passiflora Incarnata Fruit Extract, Mangifera Indica (Mango) Fruit Extract, Carica Papaya (Papaya) Fruit Extract, Iron Oxides

Other information

Protect this product from excessive heat and direct sun

Questions or Comments?

Call 1-800-NO UV RAY, Mon-Fri

Primary Display Panel

NEW

HAWAIIAN

Tropic (R)

MINERAL

SKIN NOURISHING

MILK

SUNSCREEN BROAD SPECTRUM SPF 30

UVA/UVB

REEF FRIENDLY*

CRUELTY-FREE

1 FL. OZ. (29 mL)

63354-511-21

NEW

HAWAIIAN

Tropic (R)

MINERAL

SKIN NOURISHING

MILK

SUNSCREEN BROAD SPECTRUM SPF 30

UVA/UVB

REEF FRIENDLY*

CRUELTY-FREE

3.4 FL. OZ. (100 mL)

63354-511-12

HAWAIIAN TROPIC MINERAL SUNSCREEN BROAD SPECTRUM SPF 30
titanium dioxide,zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63354-511
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	4.32 g in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	6.01 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
MINERAL OIL (UNII: T5L8T28FGP)
ALUMINUM OXIDE (UNII: LMI26O6933)
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
WATER (UNII: 059QF0KO0R)
PASSIFLORA INCARNATA FRUIT (UNII: SF206I8G4P)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
MANGO (UNII: I629I3NR86)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
PLUMERIA RUBRA FLOWER (UNII: 8P7XXY759H)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
GUAVA (UNII: 74O70D6VG0)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
KUKUI NUT OIL (UNII: TP11QR7B8R)
GLYCERYL 1-STEARATE (UNII: 258491E1RZ)
DIMETHICONE (UNII: 92RU3N3Y1O)
LAURYL PEG/PPG-18/18 METHICONE (UNII: ZJ5S27D9NX)
GLYCERIN (UNII: PDC6A3C0OX)
COCONUT OIL (UNII: Q9L0O73W7L)
ALCOHOL (UNII: 3K9958V90M)
PAPAYA (UNII: KU94FIY6JB)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:63354-511-21	28.3 g in 1 TUBE; Type 0: Not a Combination Product	11/13/2020
2	NDC:63354-511-12	96.4 g in 1 BOTTLE; Type 0: Not a Combination Product	11/13/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	11/13/2020

Labeler - Edgewell Personal Care Brands LLC (151179769)

Revised: 11/2020

Document Id: b3d921aa-ffc8-4901-e053-2a95a90a67d9

Set id: b3d921aa-ffc7-4901-e053-2a95a90a67d9

Version: 1

Effective Time: 20201111

Edgewell Personal Care Brands LLC