Hawaiian Tropic Mineral Tinted Facial Milk Sunscreen Broad Spectrum SPF 30 by Edgewell Personal Care Brands LLC

Hawaiian Tropic Mineral Tinted Facial Milk Sunscreen Broad Spectrum SPF 30 by

Drug Labeling and Warnings

Hawaiian Tropic Mineral Tinted Facial Milk Sunscreen Broad Spectrum SPF 30 by is a Otc medication manufactured, distributed, or labeled by Edgewell Personal Care Brands LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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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, Alcohol Denat., Sodium Chloride, Cocos Nucifera (Coconut) Oil, Polyhydroxystearic Acid, Glyceryl Stearate, Phenoxyethanol, Stearalkonium Bentonite, Caprylyl Glycol, Fragrance, Alumina, Mica, Propylene Carbonate, Aleurites Moluccanus Seed Oil, Ethylhexylglycerin, Triethoxycaprylylsilane, Mineral Oil, Psidium Guajava Fruit Extract, Plumeria Acutifolia Flower Extract, Passiflora Incarnata Fruit Extract, Mangifera Indica (Mango) Fruit Extract, Carica Papaya (Papaya) Fruit Extract, Bismuth Oxychloride, 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

TINTED FACIAL MILK

30

SUNSCREEN BROAD SPECTRUM SPF 30

UVA/UVB

WON'T CLOG PORES

REEF FRIENDLY*

1.7 FL. OZ. (50 mL)

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63354-635
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
SODIUM CHLORIDE (UNII: 451W47IQ8X)
COCONUT OIL (UNII: Q9L0O73W7L)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
KUKUI NUT OIL (UNII: TP11QR7B8R)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
GUAVA (UNII: 74O70D6VG0)
ALUMINUM OXIDE (UNII: LMI26O6933)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
PAPAYA (UNII: KU94FIY6JB)
PLUMERIA RUBRA FLOWER (UNII: 8P7XXY759H)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
DIMETHICONE (UNII: 92RU3N3Y1O)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
GLYCERIN (UNII: PDC6A3C0OX)
ALCOHOL (UNII: 3K9958V90M)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
LAURYL PEG/PPG-18/18 METHICONE (UNII: ZJ5S27D9NX)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
WATER (UNII: 059QF0KO0R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PASSIFLORA INCARNATA FRUIT (UNII: SF206I8G4P)
MINERAL OIL (UNII: T5L8T28FGP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MANGO (UNII: I629I3NR86)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
MICA (UNII: V8A1AW0880)
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63354-635-11	48.1 g in 1 BOTTLE; Type 0: Not a Combination Product	11/13/2020	02/28/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	11/13/2020	02/28/2023

Labeler - Edgewell Personal Care Brands LLC (151179769)

Revised: 12/2023

Document Id: 0c7e839d-b419-5bd7-e063-6294a90ab15e

34390-5

Set id: b3f54e23-fe77-7e16-e053-2a95a90a7d5a

Version: 3

Effective Time: 20231214