GOODSENSE SUNSCREEN SPF 70- avebenzone, homosalate, octisalate, oxybenzone lotion

United States - English - NLM (National Library of Medicine)

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Active ingredient:
Avobenzone 3%, Homosalate 15%, Octisalate 5%, Octocrylene 10%, Oxybenzone 6%
Available from:
Solskyn Personal Care LLC
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Sunscreen 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 Do not use on damaged or broken skin Stop use and ask a doctor if rash occurs.
Authorization status:
OTC monograph not final
Authorization number:
70281-661-24

GOODSENSE SUNSCREEN SPF 70- avebenzone, homosalate, octisalate, oxybenzone lotion

Solskyn Personal Care LLC

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.

----------

GoodSense Sunscreen Lotion SPF 70

Active Ingredients

Avobenzone 3%, Homosalate 15%, Octisalate 5%

Octocrylene 10%, Oxybenzone 6%

Purpos e

Sunscreen

Us es

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

Warnings

For external use only

Do not use

Do not use on damaged or broken skin

When using this product

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor

Stop use and ask a doctor if rash occurs.

Keep out of reach of children.

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

Re-apply 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 broad spectrum SPF of 15 or high and other

sun protection measures including:

Limit time in the sun, especially from 10a.m.-2 p.m.

Wear long-sleeved shirts, pants, hats, and sunglasses.

Children under 6 months: ask a doctor

Other Information

Protect the product in this container from excessive heat and direct sun

May stain fabric

Inactive Ingredients

Water, Glycerin, C28-52 Olefin/Undecylenic Acid Copolymer, Neopentyl Glycol Diheptanoate,

Polyglyceryl -3 Methylglucose Distearate, Tapioca Starch, Glyceryl Stearate, PEG-I00 Stearate,

Phenethyl Benzoate, Microcrystalline Cellulose, Cellulose Gum, Tocopheryl Acetate, Fragrance,

Stearic Acid, Polymethylsilsesquioxane, Caprylyl Glycol, Aloe Barbadensis Leaf Juice, Stearyl

Alcohol, Dimethicone, Disodium EDTA, Sodium Hydroxide, Phenoxyethanol

Ques tions

Distributed by Geiss, Destin, & Dunn Inc., Peach tree City, GA 30269

www.valuelabels.com /800-715-3485

*GoodSense® is a registered trademark of L. Perrigo Company *This product is not manufactured or

distributed by Bayer, the owner of the registered trademark Coppertone®

Principal Display Panel

GOODSENSE

SUNSCREEN LOTION

BROAD SPECTRUM

SPF 70

Water Resistant (80 Minutes)

UVA/UVB Protection

Hypoallergenic

Compare to active ingredients of Coppertone

100% Satisfaction Guaranteed

8 FL OZ (237 mL)

GOODSENSE SUNSCREEN SPF 70

avebenzone, homosalate, octisalate, oxybenzone lotion

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:70 28 1-6 6 1

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

HO MO SALATE (UNII: V0 6 SV4M9 5S) (HOMOSALATE - UNII:V0 6 SV4M9 5S)

HOMOSALATE

15 g in 10 0 g

O XYBENZO NE (UNII: 9 5OOS7VE0 Y) (OXYBENZONE - UNII:9 5OOS7VE0 Y)

OXYBENZONE

6 g in 10 0 g

AVO BENZO NE (UNII: G6 3QQF2NOX) (AVOBENZONE - UNII:G6 3QQF2NOX)

AVOBENZONE

3 g in 10 0 g

O CTISALATE (UNII: 4X49 Y0 59 6 W) (OCTISALATE - UNII:4X49 Y0 59 6 W)

OCTISALATE

5 g in 10 0 g

O CTO CRYLENE (UNII: 5A6 8 WGF6 WM) (OCTOCRYLENE - UNII:5A6 8 WGF6 WM)

OCTOCRYLENE

10 g in 10 0 g

Solskyn Personal Care LLC

Inactive Ingredients

Ingredient Name

Stre ng th

EDETATE DISO DIUM ANHYDRO US (UNII: 8 NLQ36 F6 MM)

PHENO XYETHANO L (UNII: HIE49 2ZZ3T)

PO LYMETHYLSILSESQ UIO XANE ( 4 .5 MICRO NS) (UNII: 59 Z9 0 7ZB6 9 )

SO DIUM HYDRO XIDE (UNII: 55X0 4QC32I)

WATER (UNII: 0 59 QF0 KO0 R)

GLYCERIN (UNII: PDC6 A3C0 OX)

UNDECYLENIC ACID (UNII: K3D8 6 KJ24N)

NEO PENTYL GLYCO L DIHEPTANO ATE (UNII: 5LKW3C543X)

PO LYGLYCERYL-3 DIISO STEARATE (UNII: 46 P231IQV8 )

STARCH, TAPIO CA (UNII: 24SC3U70 4I)

GLYCERYL STEARATE/PEG-10 0 STEARATE (UNII: RD25J5V9 47)

PHENETHYL BENZO ATE (UNII: 0 C1439 29 GK)

MICRO CRYSTALLINE CELLULO SE (UNII: OP1R32D6 1U)

CARBO XYMETHYLCELLULO SE SO DIUM, UNSPECIFIED FO RM (UNII: K6 79 OBS311)

.ALPHA.-TO CO PHERO L ACETATE (UNII: 9 E8 X8 0 D2L0 )

STEARIC ACID (UNII: 4ELV7Z6 5AP)

CAPRYLYL GLYCO L (UNII: 0 0 YIU5438 U)

ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)

DIMETHICO NE (UNII: 9 2RU3N3Y1O)

Packag ing

#

Item Code

Package Description

Marketing Start Date Marketing End Date

1

NDC:70 28 1-6 6 1-24 237 g in 1 CONTAINER; Type 0 : No t a Co mbinatio n Pro duct

0 3/22/20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt352

0 3/22/20 19

Labeler -

Solskyn Personal Care LLC (080010329)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Accra Pac, Inc.

0 242136 16

ma nufa c ture (70 28 1-6 6 1)

Revised: 7/2019

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