SUGAR CANDY LIP TREATMENT SUNSCREEN SPF 15

SUGAR CANDY LIP TREATMENT SUNSCREEN SPF 15 by

Drug Labeling and Warnings

SUGAR CANDY LIP TREATMENT SUNSCREEN SPF 15 by is a Otc medication manufactured, distributed, or labeled by Fresh Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SUGAR CANDY LIP TREATMENT SUNSCREEN SPF 15- octinoxate, oxybenzone paste 
Fresh 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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SUGAR CANDY LIP TREATMENT SUNSCREEN SPF 15

Active Ingredients

Oxybenzone 2.00%

Octinoxate 7.49%

Purpose

Sunscreen

Use

Helps prevent sunburn

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 help 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.
-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

For sunscreen use:
- Apply liberally 15 minutes before sun exposure
- Use a water resistant sunscreen if swimming or sweating
- Reapply at least every 2 hours
- Children under 6 months: Ask a doctor

Other Information

Protect this product incontainer from excessive heat and direct sun

Questions or Comments?

Call toll free 1(800)FRESH-20 Monday-Friday (9 a.m. to 5p.m EST)

Inactive Ingredients

Cera Alba (Beeswax), Simmondsia Chinensis (Jojoba) Seed Oil, Ricinus Communis (Castor) Seed Oil, Hydrogenated Olive Oil Decyl Esters, Vitis Vinifera (Grape) Seed Oil, Parfum (Fragrance), Synthetic Fluorphlogopite, Copernicia Cerifera (Carnauba) Wax, Persea Gratissima (Avocado) Oil, Limnanthes Alba (Meadowfoam) Seed Oil, Passiflora Incarnata Seed Oil, Ribes Nigrum (Black Currant) Seed Oil, Sucrose Tetrastearate Triacetate, Tocopherol, Ascorbyl Tetraisopalmitate, Ascorbyl Palmitate, Ammonium Glycyrrhizate, Polyglyceryl- 3 Polyricinoleate, Vanillin, BHT, Tin Oxide, Propyl Gallate, Limonene, Citral, Benzyl Alcohol, Linalool, Geraniol, [May Contain: CI 15850 (Red 6, Red 7, Red 7 Lake), CI 15985 (Yellow 6, Yellow 6 Lake), CI 19140 (Yellow 5, Yellow 5 Lake), CI 42090 (Blue 1 Lake), CI 45410 (Red 27, Red 27 Lake, Red 28 Lake), CI 75470 (Carmine), CI 77491, CI 77492, CI 77499 (Iron Oxides), CI 77891 (Titanium Dioxide) <11307/Z>

Labels

SUGAR CANDY LIP TREATMENT SUNSCREEN SPF 15 
octinoxate, oxybenzone paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42406-020
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	74.9 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	20 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
JOJOBA OIL (UNII: 724GKU717M)
CASTOR OIL (UNII: D5340Y2I9G)
HYDROGENATED OLIVE OIL DECYL ESTERS (UNII: XQ691JJ99N)
GRAPE SEED OIL (UNII: 930MLC8XGG)
CARNAUBA WAX (UNII: R12CBM0EIZ)
AVOCADO OIL (UNII: 6VNO72PFC1)
MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)
PASSIFLORA INCARNATA SEED OIL (UNII: S0SU5AC95J)
RIBES NIGRUM SEED OIL (UNII: GKE1188837)
SUCROSE TETRASTEARATE TRIACETATE (UNII: 1K7LBQ045N)
TOCOPHEROL (UNII: R0ZB2556P8)
ASCORBYL TETRAISOPALMITATE (UNII: 47143LT58A)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)
VANILLIN (UNII: CHI530446X)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
PROPYL GALLATE (UNII: 8D4SNN7V92)
CITRAL (UNII: T7EU0O9VPP)
BENZYL ALCOHOL (UNII: LKG8494WBH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42406-020-00	1 in 1 BOX	08/23/2016	12/31/2019
1		4.3 g in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	08/23/2016	12/31/2019

Labeler - Fresh Inc. (021403729)

Registrant - Fresh Inc. (021403729)

Revised: 1/2020

Document Id: 9b29f9a8-72f5-840b-e053-2a95a90a6d60

34390-5

Set id: 16cea1d3-5293-40eb-8c1e-24188954ea6d

Version: 4

Effective Time: 20200102

 

Fresh Inc.