Ulta Beauty Illuminating Bonzing Oil Broad Spectrum SPF 30

Ulta by

Drug Labeling and Warnings

Ulta by is a Otc medication manufactured, distributed, or labeled by Prime Enterprises, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ULTA BROAD SPECTRUM SPF 30- avobenzone, homosalate, octisalate, octocrylene oil 
Prime Enterprises, Inc.

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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Ulta Beauty Illuminating Bonzing Oil Broad Spectrum SPF 30

Active Ingredients

Avobenzone 3%, Homosalate 7.5%, Octisalate 5%, Octocrylene 5%

Purpose

Sunscreen

Uses

helps prevent sunburn

if use 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.

Flammable:

Do not use near heat, flame or while smoking.

Directions

apply liberally 15 minutes before sun exposure.

reapply: after 40 mins 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, regulary use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:

limit time in the sun, espescially from 10 a.m. - 2p.m.

wear long sleeve shirts, pants, hats, and sunglasses

children under 6 months: Ask a doctor.

Inactive ingredients

Isododecane, Ethylene/Propylene/Styrene Copolymer, Butylene/Ethylene/Styrene Copolymer, Fragrance, Phenoxyethanol, Mica, Iron Oxides, Cocos Nucifera (Coconut) Oil, Titanium Dioxide, Ethylhexylglycerin, Euterpe Oleracea Fruit Oil, Gossypium Herbaceum (Cotton) Seed Oil, Helianthus Annuus (Sunflower) Seed Oil, Theobroma Grandiflorum Seed Butter, Tocopheryl Acetate, Aloe Barbadensis Leaf Extract, Alumina

Other information:

protect this product from excessive heat and direct sun

avoid spraying on fabrics - could cause discoloration

Questions or comments?

Call 1-866-983-8582

Ulta Beauty Illuminating Bronzing Oil Broad Spectrum SPF 30

ULTA  BROAD SPECTRUM SPF 30
avobenzone, homosalate, octisalate, octocrylene oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58443-0394
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	61.88 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	24.75 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	41.25 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	41.25 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
PHENOXYETHANOL (UNII: HIE492ZZ3T)
THEOBROMA GRANDIFLORUM SEED BUTTER (UNII: I711F13FXM)
COCONUT OIL (UNII: Q9L0O73W7L)
LEVANT COTTON SEED (UNII: 550E4N439V)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ACAI OIL (UNII: Z0W6766A2W)
SUNFLOWER OIL (UNII: 3W1JG795YI)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ALUMINUM OXIDE (UNII: LMI26O6933)
ISODODECANE (UNII: A8289P68Y2)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MICA (UNII: V8A1AW0880)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Product Characteristics
Color	brown (Copper)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58443-0394-3	89 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	02/23/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	02/23/2021

Labeler - Prime Enterprises, Inc. (101946028)

Registrant - Prime Enterprises, Inc. (101946028)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Enterprises, Inc.		101946028	label(58443-0394) , pack(58443-0394) , manufacture(58443-0394) , analysis(58443-0394)

Revised: 4/2021

Document Id: bf3a962f-13c6-58e2-e053-2995a90ab7f4

34390-5

Set id: bf3ac08b-a314-5915-e053-2a95a90a79ef

Version: 1

Effective Time: 20210405