FORMOLOGY (as CMO) - Getaway Glow SPF 30 Radiant Sunscreen (<a href=/NDC/72580-110>72580-110</a>)

Drug Details [pdf]

GETAWAY GLOW SPF 30 RADIANT SUNSCREEN BROAD SPECTRUM SPF 30 SUNSCREEN- zinc oxide lotion
Formology Lab Inc.

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FORMOLOGY (as CMO) -
Getaway Glow SPF 30 Radiant Sunscreen (72580-110)

ACTIVE INGREDIENT

ZINC OXIDE 10%

PURPOSE

SUNSCREEN

USE

HELPS PREVENT SUNBURN

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 SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

DIRECTIONS

APPLY LIBERALLY 15 MINUTES BEFORE SUN EXPOSURE.
CHILDREN UNDER 6 MONTHS OF AGE: ASK A DOCTOR.
USE A WATER-RESISTANT SUNSCREEN IF SWIMMING OR SWEATING.
REAPPLY 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.

OTHER INFORMATION

PROTECT THE PRODUCT IN THIS CONTAINER FROM EXCESSIVE HEAT AND DIRECT SUN.

INACTIVE INGREDIENTS

Water (Aqua), Caprylic/Capric Triglyceride, Butylene Glycol, Diethylhexyl 2,6-Naphthalate, Polyhydroxystearic Acid, Hydroxyethyl Acrylate/Sodium, Acryloyldimethyl Taurate Copolymer, Sodium Olivate, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Jasminum Grandiflorum (Jasmine) Flower Extract, Vanilla Planifolia Fruit Oil, Tocopheryl Acetate, Xylitol, Xylitylglucoside, Anhydroxylitol, Dimethicone, Neopentyl Glycol Diethylhexanoate, Triethoxycaprylylsilane, Citric Acid, Phenoxyethanol,
Ethylhexylglycerin, Iron Oxides.

Volition Beauty SPF PDP

GETAWAY GLOW SPF 30 RADIANT SUNSCREEN BROAD SPECTRUM SPF 30 SUNSCREEN
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72580-110
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	10 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
WATER (UNII: 059QF0KO0R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
DIMETHICONE (UNII: 92RU3N3Y1O)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
CI 77499 (UNII: XM0M87F357)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
XYLITOL (UNII: VCQ006KQ1E)
SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL (UNII: 724GKU717M)
SODIUM OLIVATE (UNII: ND5Y5M6ZUT)
VANILLA PLANIFOLIA FRUIT OIL (UNII: 0A3F415158)
CITRIC ACID (UNII: 2968PHW8QP)
XYLITYLGLUCOSIDE (UNII: O0IEZ166FB)
ANHYDROXYLITOL (UNII: 8XWR7NN42F)
JASMINUM GRANDIFLORUM FLOWER (UNII: 9UJS9GG96Y)
NEOPENTYL GLYCOL DIETHYLHEXANOATE (UNII: U68ZV6W62C)
PRUNUS AMYGDALUS DULCIS (SWEET ALMOND) OIL (UNII: 66YXD4DKO9)
CI 77491 (UNII: 1K09F3G675)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC: 72580-110-12	1 in 1 BOX	11/05/2024
1	NDC: 72580-110-11	120 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	11/05/2024

Labeler - Formology Lab Inc. (081102403)

Revised: 11/2024

Document Id: 263428ea-0903-32e9-e063-6394a90a4a4b

Set id: 263457cc-35fe-62fb-e063-6394a90a94da

Version: 1

Effective Time: 20241105

FORMOLOGY (as CMO) - Getaway Glow SPF 30 Radiant Sunscreen (72580-110)

Getaway Glow SPF 30 Radiant Sunscreen by

Drug Labeling and Warnings