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NDC 82114-0001-06 Shine On Living 30A Broad Spectrum SPF 30 Sunscreen 18 g/100mL Details

Shine On Living 30A Broad Spectrum SPF 30 Sunscreen 18 g/100mL

Shine On Living 30A Broad Spectrum SPF 30 Sunscreen is a TOPICAL LOTION in the HUMAN OTC DRUG category. It is labeled and distributed by Shine On Living, LLC. The primary component is ZINC OXIDE.

Product Information

NDC	82114-0001
Product ID	82114-001_068ad85b-45bd-4b0d-8b9b-959209dc5b23
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	Shine On Living 30A Broad Spectrum SPF 30 Sunscreen
Proprietary Name Suffix	n/a
Non-Proprietary Name	Zinc Oxide
Product Type	HUMAN OTC DRUG
Dosage Form	LOTION
Route	TOPICAL
Active Ingredient Strength	18
Active Ingredient Units	g/100mL
Substance Name	ZINC OXIDE
Labeler Name	Shine On Living, LLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part352
Listing Certified Through	2024-12-31

Package

Package Images

NDC 82114-0001-06 (82114000106)

Pricing Information	N/A
NDC Package Code	82114-001-06
Billing NDC	82114000106
Package	177 mL in 1 BOTTLE (82114-001-06)
Marketing Start Date	2021-01-31
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL e9017a42-d52f-43b8-bd43-ed1ae7d5ed4a Details

Drug Facts

Active ingredient

Zinc Oxide 18%

Purpose

Sunscreen

Uses

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.

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

Stop use and ask doctor if rash occurs.

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

Directions •

Apply liberally and evenly 15 minutes prior to sun exposure
Reapply: After 40 minutes of swimming or sweating · immediately after towel drying · 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.

Other information

Protect this product from excessive heat and direct sun.

Inactive ingredients •

Aloe barbadensis leaf juice, C12-15 alkyl benzoate, caprylic/capric triglyceride, glyceryl stearate, helianthus annuus (sunflower) seed oil, ricinus communis (castor) seed oil, beeswax, oryza sativa (rice) bran wax, sorbitan sesquioleate, glycerin, cetyl alcohol, stearyl alcohol, magnesium aluminum silicate, butyrospermum parkii (shea) butter, camellia sinensis flower extract, ilex paraguariensis leaf extract, rosa canina fruit oil, tocopheryl acetate, carthamus tinctorius (safflower) seed oil, rubus idaeus (raspberry) fruit extract, squalane, xanthan gum, propanediol, ethylhexylglycerin, potassium sorbate, fragrance.

Questions?

Call us! (800) 848-7623

Face Friendly

Water Resistant (40 minutes)

Reef Safe

Packaged By: Absolutely Natural, Inc.,

640 Atlantis Rd, Melbourne, FL 32904

shineonliving.com

Packaging

INGREDIENTS AND APPEARANCE

SHINE ON LIVING 30A BROAD SPECTRUM SPF 30 SUNSCREEN

zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:82114-001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	18 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
SUNFLOWER OIL (UNII: 3W1JG795YI)
CASTOR OIL (UNII: D5340Y2I9G)
YELLOW WAX (UNII: 2ZA36H0S2V)
RICE BRAN (UNII: R60QEP13IC)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
GLYCERIN (UNII: PDC6A3C0OX)
CETYL ALCOHOL (UNII: 936JST6JCN)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
SHEA BUTTER (UNII: K49155WL9Y)
CAMELLIA SINENSIS FLOWER (UNII: 9I2BJY2J17)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SAFFLOWER OIL (UNII: 65UEH262IS)
RASPBERRY (UNII: 4N14V5R27W)
SQUALANE (UNII: GW89575KF9)
XANTHAN GUM (UNII: TTV12P4NEE)
PROPANEDIOL (UNII: 5965N8W85T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:82114-001-06	177 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/31/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	01/31/2021

Labeler - Shine On Living, LLC (073751447)

Revised: 7/2021

Document Id: 068ad85b-45bd-4b0d-8b9b-959209dc5b23

Set id: e9017a42-d52f-43b8-bd43-ed1ae7d5ed4a

Version: 1

Effective Time: 20210722