Hawaiian Tropic Mineral Skin Nourishing Milk Coconut Oil SPF30 by Edgewell Personal Care Brands LLC / Playtex Manufacturing Inc. (Ormond Beach)

Hawaiian Tropic Mineral Skin Nourishing Milk Coconut Oil SPF30 by

Drug Labeling and Warnings

Hawaiian Tropic Mineral Skin Nourishing Milk Coconut Oil SPF30 by is a Otc medication manufactured, distributed, or labeled by Edgewell Personal Care Brands LLC, Playtex Manufacturing Inc. (Ormond Beach). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HAWAIIAN TROPIC MINERAL SKIN NOURISHING MILK COCONUT OIL SPF30- titanium dioxide, zinc oxide oil 
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.

May stain some fabrics and surfaces.

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

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 longsleeved shirts, pants, hats, and
sunglasses children under 6 months: Ask a doctor.

Inactive Ingredients

Water, Caprylic/Capric Triglyceride, C12-15 Alkyl Benzoate,
Glycerin, Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Lauryl PEG-8 Dimethicone,
VP/Eicosene Copolymer, Alcohol Denat., Cocos Nucifera (Coconut) Oil, Glyceryl Stearate,
Polyhydroxystearic Acid, Sodium Chloride, Phenoxyethanol, Stearalkonium Bentonite,
Caprylyl Glycol, Fragrance, Alumina, Propylene Carbonate, Ethylhexylglycerin, Aleurites
Moluccanus Seed Oil, Triethoxycaprylylsilane, Mica, Titanium Dioxide, 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?

1-800-NO UV RAY, Mon-Fri

PRINCIPAL DISPLAY PANEL

HAWAIIAN

TROPIC

SUNSCREEN LOTION

MINERAL

SKIN NOURISHING MILK

COCONUT OIL

30

CRUELTY FREE | VEGAN
BROAD SPECTRUM SPF30 UVA/UVB

3.4 FL. OZ (100mL)

HAWAIIAN TROPIC MINERAL SKIN NOURISHING MILK COCONUT OIL SPF30 
titanium dioxide, zinc oxide oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63354-603
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	4.3 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	6 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
MICA (UNII: V8A1AW0880)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PAPAYA (UNII: KU94FIY6JB)
DIMETHICONE (UNII: 92RU3N3Y1O)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
KUKUI NUT OIL (UNII: TP11QR7B8R)
PASSIFLORA INCARNATA FRUIT (UNII: SF206I8G4P)
WATER (UNII: 059QF0KO0R)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
PLUMERIA RUBRA FLOWER (UNII: 8P7XXY759H)
MANGO (UNII: I629I3NR86)
GLYCERIN (UNII: PDC6A3C0OX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GUAVA (UNII: 74O70D6VG0)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
COCONUT OIL (UNII: Q9L0O73W7L)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ALUMINUM OXIDE (UNII: LMI26O6933)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
DEHYDRATED ALCOHOL (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63354-603-12	100 g in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2022	08/31/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	10/01/2022	08/31/2023

Labeler - Edgewell Personal Care Brands LLC (151179769)

Establishment
Name	Address	ID/FEI	Business Operations
Playtex Manufacturing Inc. (Ormond Beach)		963501502	manufacture(63354-603)

Revised: 12/2023

Document Id: 0c7e3a2a-14a9-30bb-e063-6294a90a9c5a

34390-5

Set id: efa54efb-eb9b-daae-e053-2a95a90ae2ef

Version: 2

Effective Time: 20231214