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NDC 61477-0216-26 ALOE UP DARK TANNING OIL SPF 4 2; 2 g/100mL; g/100mL Details

ALOE UP DARK TANNING OIL SPF 4 2; 2 g/100mL; g/100mL

ALOE UP DARK TANNING OIL SPF 4 is a TOPICAL SPRAY in the HUMAN OTC DRUG category. It is labeled and distributed by Aloe Care International, LLC. The primary component is OCTINOXATE; OXYBENZONE.

Product Information

NDC	61477-0216
Product ID	61477-216_dc94971d-133d-9018-e053-2a95a90ad2b2
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	ALOE UP DARK TANNING OIL SPF 4
Proprietary Name Suffix	CONTINUOUS SUNSCREEN
Non-Proprietary Name	OCTINOXATE, OXYBENZONE
Product Type	HUMAN OTC DRUG
Dosage Form	SPRAY
Route	TOPICAL
Active Ingredient Strength	2; 2
Active Ingredient Units	g/100mL; g/100mL
Substance Name	OCTINOXATE; OXYBENZONE
Labeler Name	Aloe Care International, LLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part352
Listing Certified Through	2023-12-31

Package

Package Images

NDC 61477-0216-26 (61477021626)

Pricing Information	N/A
NDC Package Code	61477-216-26
Billing NDC	61477021626
Package	177 mL in 1 BOTTLE, SPRAY (61477-216-26)
Marketing Start Date	2014-02-24
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 5e12224b-93d9-4175-a395-60aa4ff11e93 Details

ACTIVE INGREDIENTS:

OCTINOXATE (2%)

OXYBENZONE (2%)

PURPOSE:

SUNSCREEN

USES

HELPS PREVENT SUNBURN.

DIRECTIONS:

• spray liberally and spread evenly by hand 15 minutes before sun exposure.

• hold container 4 to 6 inches from the skin to apply

• do not spray directly into face. Spray on hands then apply to face.

• do not apply in windy conditions

• use in a well-ventilated area

• reapply:

• after 80 minutes of swimming or sweating

• immediately after towel drying

• at least every 2 hours

•children under 6 months: Ask a doctor

SPL UNCLASSIFIED SECTION

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

WARNINGS:

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

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.

Keep away from face to avoid breathing it. Contents under pressure - do not puncture or incinerate. Do not store at temperatures above 120°F.

Stop use and ask a doctor if rash occurs.

Flammable: Do not use near heat, flame or while smoking.

Inactive Ingredients

Acrylates/Octylacrylamide Copolymer, Aloe Barbadensis Extract, Ascorbic Acid (Vitamin C), C12-15 Alkyl Benzoate, Castor Oil, Cocos Nucifera (Coconut) Oil, Fragrance, Mineral Oil, Retinyl Palmitate (Vitamin A), SD Alcohol 40-B, Tocopheryl Acetate (Vitamin E)

Other Information

• protect this product from excessive heat and direct sun

• avoid spraying on fabrics - could cause discoloration.

Questions or Comments?

Call toll free 1-800-950-2563 • www.aloeup.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ALOE UP DARK TANNING OIL SPF 4 CONTINUOUS SUNSCREEN

octinoxate, oxybenzone spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:61477-216
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2 g in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	2 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CASTOR OIL (UNII: D5340Y2I9G)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
COCONUT OIL (UNII: Q9L0O73W7L)
MINERAL OIL (UNII: T5L8T28FGP)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
ALCOHOL (UNII: 3K9958V90M)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:61477-216-26	177 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	02/24/2014

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	02/24/2014

Labeler - Aloe Care International, LLC (938242187)

Registrant - Aloe Care International, LLC (938242187)

Revised: 4/2022

Document Id: dc94971d-133d-9018-e053-2a95a90ad2b2

Set id: 5e12224b-93d9-4175-a395-60aa4ff11e93

Version: 8

Effective Time: 20220413