DAILY SHIELD BROAD SPECTRUM SPF 20 MOISTURIZER- avobenzone, homosalate, octisalate, octocrylene lotion

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

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Active ingredient:
AVOBENZONE 3.0%, HOMOSALATE 10.0%, OCTISALATE 5.0%, OCTOCTYLENE 7.0%
Available from:
ASPIRE BRANDS INC
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.
Authorization status:
OTC monograph final
Authorization number:
70626-202-51

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DAILY SHIELD BROAD SPECTRUM SPF 20 MOISTURIZER- avobenzone, homosalate,

octisalate, octocrylene lotion

ASPIRE BRANDS 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.

----------

FORMULA 10.0.6 DAILY SHIELD BROAD SPECTRUM SPF 20 MOISTURIZER

ACTIVE INGREDIENTS

AVOBENZONE 3.0%

HOMOSALATE 10.0%

OCTISALATE 5.0%

OCTOCTYLENE 7.0%

PURPOSE

SUNSCREEN

USE

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 ON DAMAGED OR BROKEN SKIN

STOP USE AND ASK A DOCTOR IF RASH OCCURS.

WHEN USING THIS PRODUCT KEEP OUT OF EYES. RINSE WITH WATER TO REMOVE.

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

USE A WATER RESISTANT SUNSCREEN IF SWIMMING OR SWEATING

REAPPLY AT LEAST EVERY 2 HOURS

CHILDREN UNDER 6 MONTHS OF AGE: ASK A DOCTOR

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.

PROTECT THIS PRODUCT FROM EXCESSIVE HEAT AND DIRECT SUN

INACTIVE INGREDIENTS

WATER, BUTYLENE GLYCOL, TRIBEHENIN PEG-20 ESTERS, ISOCETYL STEAROYL

STEARATE, DIMETHICONE, BUTYROSPERMUM PARKII (SHEA BUTTER), CETYL

ALCOHOL, POLYETHYLENE, LAURETH-4, CAPRYLYL GLYCOL, POTASSIUM CETYL

PHOSPHATE, PHENOXYETHANOL, PENTYLENE GLYCOL, PEG-100 STEARATE, GLYCERYL

STEARATE, GLYCERIN, HYDROGENATED LECITHIN, ACYLATES/C10-30 ALKYL

ACRYLATE CROSSPOLYMER, ACRYLAMIDE/SODIUM ACRYLOYLDIMETHYLTAURATE

COPOLYMER, SODIUM HYDROXIDE, ISOHEXADECANE, HEXYLENE GLYCOL,

ETHYLHEXYLGLYCERIN, TOCOPHERYL ACETATE, SODIUM ASCORBYL PHOSPHATE,

PUNICA GRANATUM FRUIT EXTRACT, HYDROLYZED JOJOBA ESTERS, DISODIUM EDTA,

ALLYL METHACRYLATES CROSSPOLYMER, POLYSORBATE 80, N-PROLYL PALMITOYL

TRIPEPTIDE-56 ACETATE, SODIUM HYALURONATE, YELLOW 5, RED 40.

QUESTIONS OR COMMENTS?

CALL 1-866-984-1433

DAILY SHIELD BROAD SPECTRUM SPF 20 MOISTURIZER

avobenzone, homosalate, octisalate, octocrylene lotion

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:70 6 26 -20 2

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

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

AVOBENZONE

3 g in 10 0 mL

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

HOMOSALATE

10 g in 10 0 mL

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

OCTISALATE

5 g in 10 0 mL

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

OCTOCRYLENE

7 g in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

BUTYLENE GLYCO L (UNII: 3XUS8 5K0 RA)

TRIBEHENIN PEG-2 0 ESTERS (UNII: 8 4K9 EH29 Y9 )

ISO CETYL STEARO YL STEARATE (UNII: IJV4LS38 3R)

DIMETHICO NE (UNII: 9 2RU3N3Y1O)

SHEA BUTTER (UNII: K49 155WL9 Y)

CETYL ALCO HO L (UNII: 9 36 JST6 JCN)

LO W DENSITY PO LYETHYLENE (UNII: J245LN42AI)

LAURETH-4 (UNII: 6 HQ8 5579 8 J)

CAPRYLYL GLYCO L (UNII: 0 0 YIU5438 U)

PO TASSIUM CETYL PHO SPHATE (UNII: 0 3KCY6 P7UT)

PHENO XYETHANO L (UNII: HIE49 2ZZ3T)

PENTYLENE GLYCO L (UNII: 50 C130 7PZG)

PEG-10 0 STEARATE (UNII: YD0 1N19 9 9 R)

GLYCERYL MO NO STEARATE (UNII: 230 OU9 XXE4)

GLYCERIN (UNII: PDC6 A3C0 OX)

HYDRO GENATED SO YBEAN LECITHIN (UNII: H110 9 Z9 J4N)

CARBO MER INTERPO LYMER TYPE A ( ALLYL SUCRO SE CRO SSLINKED) (UNII: 59 TL3WG5CO)

SO DIUM ACRYLO YLDIMETHYLTAURATE-ACRYLAMIDE CO PO LYMER ( 1:1; 9 0 0 0 0 -150 0 0 0 MPA.S) (UNII:

5F49 6 3KLHS)

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

ISO HEXADECANE (UNII: 9 18 X1OUF1E)

HEXYLENE GLYCO L (UNII: KEH0 A3F75J)

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

SO DIUM ASCO RBYL PHO SPHATE (UNII: 8 36 SJG51DR)

PO MEGRANATE (UNII: 56 6 8 7D1Z4D)

HYDRO LYZED JO JO BA ESTERS ( ACID FO RM) (UNII: UDR6 41JW8 W)

EDETATE DISO DIUM (UNII: 7FLD9 1C8 6 K)

ALLYL METHACRYLATE (UNII: G2IG50 6 53Z)

PO LYSO RBATE 8 0 (UNII: 6 OZP39 ZG8 H)

N-PRO LYL PALMITO YL TRIPEPTIDE-56 ACETATE (UNII: 5YX5BR41EQ)

HYALURO NATE SO DIUM (UNII: YSE9 PPT4TH)

FD&C YELLO W NO . 5 (UNII: I753WB2F1M)

FD&C RED NO . 4 0 (UNII: WZB9 127XOA)

Packag ing

ASPIRE BRANDS INC

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:70 6 26 -20 2-51

1 in 1 BOX

12/0 6 /20 20

1

45 mL in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt352

12/0 6 /20 20

Labeler -

ASPIRE BRANDS INC (832462811)

Revised: 12/2020

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